Get insight into Food/Cosmetics enforcement with the FDAta appby datagemba.net

21 CFR 1.234 - How and when do you update your facility's registration information?

21 CFR 1.225 - Who must register under this subpart?

21 CFR 1.510(a)(1) - (1) You must keep records as original records, true copies (such as photocopies, pictures, scanne...

21 CFR 1.510(a)(2) - (2) You must sign and date records concerning your FSVP upon initial completion and upon any modi...

21 CFR 1.510(b)(1) - (1) You must make all records required under this subpart available promptly to an authorized FDA...

21 CFR 1.510(b)(3) - (3) If requested in writing by FDA, you must send records to the Agency electronically, or throug...

21 CFR 1.510(c)(1) - (1) Except as specified in paragraph (c)(2) of this section, you must retain records referenced i...

21 CFR 1.506(b) - (b) Foreign supplier verification procedures. You must establish and follow adequate written pro...

21 CFR 1.506(c) - (c) Requirement of supplier verification. The foreign supplier verification activities must prov...

21 CFR 1.506(d)(2) - (2) Verification activities for certain serious hazards. When a hazard in a food will be control...

21 CFR 1.506(d)(3) - (3) Reliance on a determination by another entity. You may rely on a determination of appropriat...

21 CFR 1.506(d)(1)(i) - (i) General. Except as provided in paragraphs (d)(2) and (3) of this section, before importing a...

21 CFR 1.506(d)(1)(ii) - (ii) Appropriate verification activities. The following are appropriate supplier verification ac...

21 CFR 1.506(e)(3) - (3) Review of results of verification activities. You must promptly review and assess the result...

21 CFR 1.506(e)(1) - (1) Verification activities

21 CFR 1.506(e)(1)(ii) - (ii) Sampling and testing of the food. You must retain documentation of each sampling and testin...

21 CFR 1.506(e)(1)(iii) - (iii) Review of the foreign supplier's relevant food safety records. You must retain documentati...

21 CFR 1.506(e)(1)(i)(B) - (B) If the food is subject to one or more FDA food safety regulations, an onsite audit of the for...

21 CFR 1.506(e)(1)(i)(D) - (D) You must retain documentation of each onsite audit, including the audit procedures, the dates...

21 CFR 1.506(e)(1)(i)(E) - (E) The following inspection results may be substituted for an onsite audit, provided that the in...

21 CFR 1.506(e)(1)(iv)(B) - (B) You must retain documentation of each activity conducted in accordance with paragraph (e)(1)(...

21 CFR 1.506(e)(2)(ii) - (ii) You may not rely on the foreign supplier itself or employees of the foreign supplier to perf...

21 CFR 1.506(a)(1) - (1) You must establish and follow written procedures to ensure that you import foods only from fo...

21 CFR 1.506(a)(2) - (2) You may rely on an entity other than your foreign supplier to establish the procedures and pe...

21 CFR 1.508(a) - (a) You must promptly take appropriate corrective actions if you determine that a foreign supplie...

21 CFR 1.508(b) - (b) If you determine, by means other than the verification activities conducted under § 1.506 or ...

21 CFR 1.507(a) - (a) Circumstances

21 CFR 1.507(a)(1) - (1) You determine and document that the type of food (e.g., raw agricultural commodities such as ...

21 CFR 1.507(a)(2)(i) - (i) Disclose in documents accompanying the food, in accordance with the practice of the trade, th...

21 CFR 1.507(a)(2)(ii) - (ii) Annually obtain from your customer written assurance, subject to the requirements of paragra...

21 CFR 1.507(a)(3)(i) - (i) Disclose in documents accompanying the food, in accordance with the practice of the trade, th...

21 CFR 1.502(a) - (a) General. Except as specified in paragraph (b) of this section, for each food you import, you...

21 CFR 1.502(b)(1) - (1) Importers of low-acid canned foods not subject to further manufacturing or processing. With ...

21 CFR 1.512(c)(1)(i) - (i) Initial evaluation. Except as specified in paragraph (c)(1)(iii) of this section, in approvi...

21 CFR 1.512(c)(1)(iii) - (iii) Review of another entity's evaluation or reevaluation of foreign supplier compliance histor...

21 CFR 1.512(c)(3)(i) - (i) You must establish and follow written procedures to ensure that you import foods only from fo...

21 CFR 1.512(b)(2) - (2) Additional requirements. If this section applies and you choose to comply with the requireme...

21 CFR 1.512(b)(4) - (4) Corrective actions. You must promptly take appropriate corrective actions if you determine t...

21 CFR 1.512(b)(1)(ii) - (ii) Small foreign supplier status. If you are a importing food from a small foreign supplier as...

21 CFR 1.512(b)(1)(i)(A) - (A) If you are a very small importer and you choose to comply with the requirements in this secti...

21 CFR 1.512(b)(3)(i) - (i) If you are a very small importer, for each food you import, you must obtain written assurance...

21 CFR 1.512(b)(3)(ii) - (ii) If your foreign supplier is a qualified facility as defined by § 117

21 CFR 1.512(b)(3)(ii)(A) - (A) A brief description of the preventive controls that the supplier is implementing to control t...

21 CFR 1.512(b)(5)(i)(B) - (B) You must sign and date records concerning your FSVP upon initial completion and upon any modi...

21 CFR 1.512(b)(5)(ii)(A) - (A) You must make all records required under this subpart available promptly to an authorized FDA...

21 CFR 1.512(b)(5)(ii)(C) - (C) If requested in writing by FDA, you must send records to the Agency electronically or through...

21 CFR 1.512(b)(5)(iii)(B) - (B) If you are subject to paragraph (c) of this section, you must retain records that relate to y...

21 CFR 1.513(a)(1) - (1) If you meet the conditions and requirements of paragraph (b) of this section for a food of th...

21 CFR 1.513(b)(1) - (1) Before importing a food from the foreign supplier and annually thereafter, you must document ...

21 CFR 1.513(b)(2) - (2) Before importing a food from the foreign supplier, you must determine and document whether th...

21 CFR 1.503(a) - (a) Qualified individual. A qualified individual must develop your FSVP and perform each of the ...

21 CFR 1.511(b) - (b) Importers whose customer is subject to certain requirements in the dietary supplement current...

21 CFR 1.511(c)(1) - (1) General. If the food you import is a dietary supplement and neither paragraph (a) or (b) of ...

21 CFR 1.511(c)(3) - (3) Foreign supplier verification procedures. You must establish and follow adequate written pro...

21 CFR 1.511(c)(2)(i) - (i) You must establish and follow written procedures to ensure that you import foods only from fo...

21 CFR 1.511(c)(2)(ii) - (ii) You may rely on an entity other than the foreign supplier to establish the procedures and pe...

21 CFR 1.511(c)(5)(i)(B) - (B) Sampling and testing of the food. You must retain documentation of each sampling and testing...

21 CFR 1.511(c)(5)(i)(C) - (C) Review of the foreign supplier's food safety records. You must retain documentation of each ...

21 CFR 1.511(c)(5)(i)(A)(4) - (4) You must retain documentation of each onsite audit, including the audit procedures, the dates...

21 CFR 1.505(d) - (d) Review of another entity's evaluation or reevaluation of a foreign supplier's performance and...

21 CFR 1.505(b) - (b) Approval of foreign suppliers. You must approve your foreign suppliers on the basis of the e...

21 CFR 1.505(c)(1) - (1) Except as specified in paragraph (d) of this section, you must promptly reevaluate the concer...

21 CFR 1.505(c)(2) - (2) If at the end of any 3-year period you have not reevaluated the concerns associated with the ...

21 CFR 1.505(a)(2) - (2) You must document the evaluation you conduct under paragraph (a)(1) of this section.

21 CFR 1.504(e) - (e) Hazards in raw agricultural commodities that are fruits or vegetables. If you are importing ...

21 CFR 1.504(a) - (a) Requirement for a hazard analysis. Except as specified in paragraph (d) of this section, you...

21 CFR 1.504(d) - (d) Review of another entity's hazard analysis. If another entity (including your foreign suppli...

21 CFR 1.504(b)(1) - (1) Your analysis of the known or reasonably foreseeable hazards in each food must include the fo...

21 CFR 1.504(c)(1) - (1) Your hazard analysis must include an evaluation of the hazards identified in paragraph (b) of...

21 CFR 1.504(c)(2) - (2) The hazard evaluation required by paragraph (c)(1) of this section must include an evaluation...

21 CFR 1.504(c)(3) - (3) Your hazard evaluation must consider the effect of the following on the safety of the finishe...

21 CFR 1.509(b) - (b) Before an article of food is imported or offered for import into the United States, the forei...

21 CFR 1.509(a) - (a) You must ensure that, for each line entry of food product offered for importation into the Un...

21 CFR 1.908(d) - (d) Requirements applicable to receivers engaged in transportation operations. Upon receipt of f...

21 CFR 1.908(a)(3) - (3) All transportation operations must be conducted under such conditions and controls necessary ...

21 CFR 1.908(a)(6) - (6) If a shipper, loader, receiver, or carrier becomes aware of an indication of a possible mater...

21 CFR 1.908(b) - (b) Requirements applicable to shippers engaged in transportation operations

21 CFR 1.908(b)(2) - (2) Unless the shipper takes other measures in accordance with paragraph (b)(5) of this section t...

21 CFR 1.908(e)(6)(iii) - (iii) Describe how it will comply with the provisions for the use of bulk vehicles in paragraphs ...

21 CFR 106.30(f) - (f) A manufacturer shall ensure that equipment and utensils used in the manufacture of infant for...

21 CFR 106.30(g) - (g) A manufacturer shall ensure that compressed air or other gases that are mechanically introduc...

21 CFR 106.30(d) - (d) A manufacturer shall ensure that each instrument used for measuring, regulating, or controlli...

21 CFR 106.30(a) - (a) A manufacturer shall ensure that equipment and utensils used in the manufacture, processing, ...

21 CFR 106.30(e)(5) - (5) A manufacturer shall monitor the temperature in thermal processing equipment at points where ...

21 CFR 106.30(e)(2)(ii) - (ii) A manufacturer may maintain a cold storage area for an in-process infant formula or for a fi...

21 CFR 106.30(e)(3)(ii)(C) - (C) Equipping the cold storage compartment with a high temperature alarm that has been validated ...

21 CFR 106.30(b) - (b) A manufacturer shall ensure that equipment and utensils used in the manufacture, processing, ...

21 CFR 106.30(b)(3) - Our records indicate this regulation is no longer in the CFR. See ecfr.gov for more information

21 CFR 106.20(d) - (d) A manufacturer shall provide adequate ventilation or control equipment to minimize odors and ...

21 CFR 106.20(a) - (a) Buildings used in the manufacture, processing, packing, or holding of infant formula shall be...

21 CFR 106.20(i) - (i) Each infant formula manufacturing site shall provide its employees with readily accessible to...

21 CFR 106.20(f)(3) - (3) A manufacturer shall conduct the tests required by paragraph (f)(2) of this section with suff...

21 CFR 106.10(a) - (a) A manufacturer shall employ sufficient personnel, qualified by education, training, or experi...

21 CFR 106.10(b)(1) - (1) Wearing clean outer garments and, as necessary, protective apparel such as head, face, hand, ...

21 CFR 106.10(b)(2) - (2) Washing hands thoroughly in a hand washing facility with soap and running water at a suitable...

21 CFR 106.55(c) - (c) A manufacturer of powdered infant formula shall test representative samples of each productio...

21 CFR 106.55(a) - (a) A manufacturer of infant formula shall establish a system of process controls covering all st...

21 CFR 106.50(e) - (e) A manufacturer shall establish controls that ensure that the equipment used at points where c...

21 CFR 106.50(f)(1) - (1) For any specification established in accordance with § 106.6(c)(1) that a manufacturer fails ...

21 CFR 106.35(b) - (b) All systems shall be designed, installed, tested, and maintained in a manner that will ensure...

21 CFR 106.6(a) - (a) A manufacturer shall conform to the requirements of this subpart by implementing a system of ...

21 CFR 106.6(c)(2) - (2) Monitor the production and in-process control point, step, or stage;

21 CFR 106.92(b) - (b) The audits required by paragraph (a) of this section shall be performed by an individual or a...

21 CFR 106.91(a)(1) - (1) Each nutrient premix used in the manufacture of an infant formula shall be tested for each nu...

21 CFR 106.91(a)(4) - (4) During the manufacturing process or at the final product stage, before distribution, each pro...

21 CFR 106.91(b)(1)(i) - (i) For an infant formula that is a new infant formula the manufacturer shall collect, from each ...

21 CFR 106.100(j) - (j) The manufacturer shall make and retain records pertaining to regularly scheduled audits, incl...

21 CFR 106.100(c) - (c) The manufacturer shall maintain all records that pertain to nutrient premix testing that it g...

21 CFR 106.100(d) - (d) The premix supplier shall maintain the results of all testing conducted to provide all certif...

21 CFR 106.100(k) - (k) The manufacturer shall maintain procedures describing how all written and oral complaints reg...

21 CFR 106.100(k)(2) - (2) When a complaint shows that a hazard to health possibly exists, the manufacturer shall conduc...

21 CFR 106.100(f)(2) - (2) Records, in accordance with § 106.30(d), of accuracy checks of instruments and controls. A ce...

21 CFR 106.100(f)(4) - (4) Records, in accordance with § 106.30(f), on equipment cleaning, sanitizing, and maintenance t...

21 CFR 107.50(e)(2) - (2) The manufacturer shall promptly notify the Food and Drug Administration when the manufacturer...

21 CFR 108.25(f) - (f) All plant personnel involved in acidification, pH control, heat treatment, or other critical ...

21 CFR 108.25(d) - (d) A commercial processor engaged in the processing of acidified foods shall promptly report to ...

21 CFR 108.25(g) - (g) A commercial processor engaged in the processing of acidified foods shall prepare, review, an...

21 CFR 108.25(e) - (e) A commercial processor engaged in the processing of acidified foods shall prepare and maintai...

21 CFR 108.25(c)(1) - (1) Registration. A commercial processor, when first engaging in the manufacture, processing, or...

21 CFR 108.25(c)(2) - (2) Process filing. A commercial processor engaged in the processing of acidified foods shall, n...

21 CFR 108.25(c)(3)(i) - (i) Scheduling. A commercial processor engaged in processing acidified foods in any registered e...

21 CFR 108.25(c)(3)(ii) - (ii) Process and pH information availability. When requested by the Food and Drug Administration...

21 CFR 108.35(e) - (e) A commercial processor engaged in thermal processing of low-acid foods packaged in hermetical...

21 CFR 108.35(g) - (g) All operators of retorts, thermal processing systems, aseptic processing and packaging system...

21 CFR 108.35(h) - (h) A commercial processor engaged in the thermal processing of low-acid foods packaged in hermet...

21 CFR 108.35(d) - (d) A commercial processor engaged in the thermal processing of low-acid foods packaged in hermet...

21 CFR 108.35(f) - (f) A commercial processor engaged in the thermal processing of low-acid foods packaged in hermet...

21 CFR 108.35(c)(1) - (1) Registration. A commercial processor when first engaging in the manufacture, processing, or ...

21 CFR 108.35(c)(2) - (2) Process filing

21 CFR 108.35(c)(2)(i) - (i) If all the necessary information is not available for existing products, the processor shall,...

21 CFR 108.35(c)(2)(ii) - (ii) If a packer intentionally makes a change in a previously filed scheduled process by reducing...

21 CFR 108.35(c)(3)(i) - (i) A commercial processor engaged in the thermal processing of low-acid foods packaged in hermet...

21 CFR 108.35(c)(3)(ii) - (ii) Process information availability: When requested by the Food and Drug Administration in writ...

21 CFR 110.10(d) - (d) Supervision. Responsibility for assuring compliance by all personnel with all requirements o...

21 CFR 110.10(a) - (a) Disease control. Any person who, by medical examination or supervisory observation, is shown...

21 CFR 110.10(c) - (c) Education and training. Personnel responsible for identifying sanitation failures or food co...

21 CFR 110.10(b)(1) - (1) Wearing outer garments suitable to the operation in a manner that protects against the contam...

21 CFR 110.10(b)(2) - (2) Maintaining adequate personal cleanliness.

21 CFR 110.10(b)(3) - (3) Washing hands thoroughly (and sanitizing if necessary to protect against contamination with u...

21 CFR 110.10(b)(4) - (4) Removing all unsecured jewelry and other objects that might fall into food, equipment, or con...

21 CFR 110.10(b)(5) - (5) Maintaining gloves, if they are used in food handling, in an intact, clean, and sanitary cond...

21 CFR 110.10(b)(6) - (6) Wearing, where appropriate, in an effective manner, hair nets, headbands, caps, beard covers,...

21 CFR 110.10(b)(7) - (7) Storing clothing or other personal belongings in areas other than where food is exposed or wh...

21 CFR 110.10(b)(8) - (8) Confining the following to areas other than where food may be exposed or where equipment or u...

21 CFR 110.10(b)(9) - (9) Taking any other necessary precautions to protect against contamination of food, food-contact...

21 CFR 110.37(a) - (a) Water supply. The water supply shall be sufficient for the operations intended and shall be ...

21 CFR 110.37(f) - (f) Rubbish and offal disposal. Rubbish and any offal shall be so conveyed, stored, and disposed...

21 CFR 110.37(c) - (c) Sewage disposal. Sewage disposal shall be made into an adequate sewerage system or disposed ...

21 CFR 110.37(b)(1) - (1) Carry sufficient quantities of water to required locations throughout the plant.

21 CFR 110.37(b)(2) - (2) Properly convey sewage and liquid disposable waste from the plant.

21 CFR 110.37(b)(3) - (3) Avoid constituting a source of contamination to food, water supplies, equipment, or utensils ...

21 CFR 110.37(b)(4) - (4) Provide adequate floor drainage in all areas where floors are subject to flooding-type cleani...

21 CFR 110.37(b)(5) - (5) Provide that there is not backflow from, or cross-connection between, piping systems that dis...

21 CFR 110.37(d) - (d) Toilet facilities

21 CFR 110.37(d)(1) - (1) Maintaining the facilities in a sanitary condition.

21 CFR 110.37(d)(2) - (2) Keeping the facilities in good repair at all times.

21 CFR 110.37(d)(3) - (3) Providing self-closing doors.

21 CFR 110.37(d)(4) - (4) Providing doors that do not open into areas where food is exposed to airborne contamination, ...

21 CFR 110.37(e) - (e) Hand-washing facilities

21 CFR 110.37(e)(1) - (1) Hand-washing and, where appropriate, hand-sanitizing facilities at each location in the plant...

21 CFR 110.37(e)(2) - (2) Effective hand-cleaning and sanitizing preparations.

21 CFR 110.37(e)(3) - (3) Sanitary towel service or suitable drying devices.

21 CFR 110.37(e)(4) - (4) Devices or fixtures, such as water control valves, so designed and constructed to protect aga...

21 CFR 110.37(e)(5) - (5) Readily understandable signs directing employees handling unprotected food, unprotected food-...

21 CFR 110.37(e)(6) - (6) Refuse receptacles that are constructed and maintained in a manner that protects against cont...

21 CFR 110.35(a) - (a) General maintenance. Buildings, fixtures, and other physical facilities of the plant shall b...

21 CFR 110.35(e) - (e) Storage and handling of cleaned portable equipment and utensils. Cleaned and sanitized porta...

21 CFR 110.35(c) - (c) Pest control. No pests shall be allowed in any area of a food plant. Guard or guide dogs may...

21 CFR 110.35(d) - (d) Sanitation of food-contact surfaces

21 CFR 110.35(d)(1) - (1) Food-contact surfaces used for manufacturing or holding low-moisture food shall be in a dry, ...

21 CFR 110.35(d)(2) - (2) In wet processing, when cleaning is necessary to protect against the introduction of microorg...

21 CFR 110.35(d)(3) - (3) Non-food-contact surfaces of equipment used in the operation of food plants should be cleaned...

21 CFR 110.35(d)(4) - (4) Single-service articles (such as utensils intended for one-time use, paper cups, and paper to...

21 CFR 110.35(d)(5) - (5) Sanitizing agents shall be adequate and safe under conditions of use. Any facility, procedure...

21 CFR 110.35(b)(1) - (1) Cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures shall be ...

21 CFR 110.35(b)(2) - (2) Toxic cleaning compounds, sanitizing agents, and pesticide chemicals shall be identified, hel...

21 CFR 110.20(b)(1) - (1) Provide sufficient space for such placement of equipment and storage of materials as is neces...

21 CFR 110.20(b)(2) - (2) Permit the taking of proper precautions to reduce the potential for contamination of food, fo...

21 CFR 110.20(b)(3) - (3) Permit the taking of proper precautions to protect food in outdoor bulk fermentation vessels ...

21 CFR 110.20(b)(4) - (4) Be constructed in such a manner that floors, walls, and ceilings may be adequately cleaned an...

21 CFR 110.20(b)(5) - (5) Provide adequate lighting in hand-washing areas, dressing and locker rooms, and toilet rooms ...

21 CFR 110.20(b)(6) - (6) Provide adequate ventilation or control equipment to minimize odors and vapors (including ste...

21 CFR 110.20(b)(7) - (7) Provide, where necessary, adequate screening or other protection against pests.

21 CFR 110.20(a) - (a) Grounds

21 CFR 110.20(a)(1) - (1) Properly storing equipment, removing litter and waste, and cutting weeds or grass within the ...

21 CFR 110.20(a)(2) - (2) Maintaining roads, yards, and parking lots so that they do not constitute a source of contami...

21 CFR 110.20(a)(3) - (3) Adequately draining areas that may contribute contamination to food by seepage, foot-borne fi...

21 CFR 110.20(a)(4) - (4) Operating systems for waste treatment and disposal in an adequate manner so that they do not ...

21 CFR 110.40(b) - (b) Seams on food-contact surfaces shall be smoothly bonded or maintained so as to minimize accum...

21 CFR 110.40(d) - (d) Holding, conveying, and manufacturing systems, including gravimetric, pneumatic, closed, and ...

21 CFR 110.40(a) - (a) All plant equipment and utensils shall be so designed and of such material and workmanship as...

21 CFR 110.40(c) - (c) Equipment that is in the manufacturing or food-handling area and that does not come into cont...

21 CFR 110.40(g) - (g) Compressed air or other gases mechanically introduced into food or used to clean food-contact...

21 CFR 110.40(e) - (e) Each freezer and cold storage compartment used to store and hold food capable of supporting g...

21 CFR 110.40(f) - (f) Instruments and controls used for measuring, regulating, or recording temperatures, pH, acidi...

21 CFR 110.93 - Warehousing and distribution.

21 CFR 110.80 - Processes and controls.

21 CFR 110.80(b) - (b) Manufacturing operations

21 CFR 110.80(b)(1) - (1) Equipment and utensils and finished food containers shall be maintained in an acceptable cond...

21 CFR 110.80(b)(10) - (10) Mechanical manufacturing steps such as washing, peeling, trimming, cutting, sorting and insp...

21 CFR 110.80(b)(12) - (12) Batters, breading, sauces, gravies, dressings, and other similar preparations shall be treat...

21 CFR 110.80(b)(13) - (13) Filling, assembling, packaging, and other operations shall be performed in such a way that t...

21 CFR 110.80(b)(14) - (14) Food such as, but not limited to, dry mixes, nuts, intermediate moisture food, and dehydrate...

21 CFR 110.80(b)(15) - (15) Food such as, but not limited to, acid and acidified food, that relies principally on the co...

21 CFR 110.80(b)(16) - (16) When ice is used in contact with food, it shall be made from water that is safe and of adequ...

21 CFR 110.80(b)(2) - (2) All food manufacturing, including packaging and storage, shall be conducted under such condit...

21 CFR 110.80(b)(3) - (3) Food that can support the rapid growth of undesirable microorganisms, particularly those of p...

21 CFR 110.80(b)(4) - (4) Measures such as sterilizing, irradiating, pasteurizing, freezing, refrigerating, controlling...

21 CFR 110.80(b)(5) - (5) Work-in-process shall be handled in a manner that protects against contamination.

21 CFR 110.80(b)(6) - (6) Effective measures shall be taken to protect finished food from contamination by raw material...

21 CFR 110.80(b)(7) - (7) Equipment, containers, and utensils used to convey, hold, or store raw materials, work-in-pro...

21 CFR 110.80(b)(8) - (8) Effective measures shall be taken to protect against the inclusion of metal or other extraneo...

21 CFR 110.80(b)(9) - (9) Food, raw materials, and other ingredients that are adulterated within the meaning of the act...

21 CFR 110.80(a)(1) - (1) Raw materials and other ingredients shall be inspected and segregated or otherwise handled as...

21 CFR 110.80(a)(2) - (2) Raw materials and other ingredients shall either not contain levels of microorganisms that ma...

21 CFR 110.80(a)(3) - (3) Raw materials and other ingredients susceptible to contamination with aflatoxin or other natu...

21 CFR 110.80(a)(4) - (4) Raw materials, other ingredients, and rework susceptible to contamination with pests, undesir...

21 CFR 110.80(a)(5) - (5) Raw materials, other ingredients, and rework shall be held in bulk, or in containers designed...

21 CFR 110.80(a)(6) - (6) Frozen raw materials and other ingredients shall be kept frozen. If thawing is required prior...

21 CFR 110.80(a)(7) - (7) Liquid or dry raw materials and other ingredients received and stored in bulk form shall be h...

21 CFR 110.110(d) - (d) The mixing of a food containing defects above the current defect action level with another lo...

21 CFR 110.110(c) - (c) Compliance with defect action levels does not excuse violation of the requirement in section ...

21 CFR 111.12(c) - (c) Each person engaged in manufacturing, packaging, labeling, or holding, or in performing any q...

21 CFR 111.12(a) - (a) You must have qualified employees who manufacture, package, label, or hold dietary supplement...

21 CFR 111.12(b) - (b) You must identify who is responsible for your quality control operations. Each person who is ...

21 CFR 111.12 - What personnel qualification requirements apply?

21 CFR 111.14(a) - (a) You must make and keep records required under this subpart B in accordance with subpart P of ...

21 CFR 111.14(b)(1) - (1) Written procedures for fulfilling the requirements of this subpart B; and

21 CFR 111.14(b)(2) - (2) Documentation of training, including the date of the training, the type of training, and the ...

21 CFR 111.10(a) - (a) Preventing microbial contamination

21 CFR 111.10(a)(2) - (2) Instructing your employees to notify their supervisor(s) if they have or if there is a reason...

21 CFR 111.10(b) - (b) Hygienic practices

21 CFR 111.10(b)(1) - (1) Wearing outer garments in a manner that protects against the contamination of components, die...

21 CFR 111.10(b)(2) - (2) Maintaining adequate personal cleanliness;

21 CFR 111.10(b)(3) - (3) Washing hands thoroughly (and sanitizing if necessary to protect against contamination with m...

21 CFR 111.10(b)(4) - (4) Removing all unsecured jewelry and other objects that might fall into components, dietary sup...

21 CFR 111.10(b)(5) - (5) Maintaining gloves used in handling components or dietary supplements in an intact, clean, an...

21 CFR 111.10(b)(6) - (6) Wearing, where appropriate, in an effective manner, hair nets, caps, beard covers, or other e...

21 CFR 111.10(b)(7) - (7) Not storing clothing or other personal belongings in areas where components, dietary suppleme...

21 CFR 111.10(b)(8) - (8) Not eating food, chewing gum, drinking beverages, or using tobacco products in areas where co...

21 CFR 111.10(b)(9) - (9) Taking any other precautions necessary to protect against the contamination of components, di...

21 CFR 111.8 - What are the requirements under this subpart B for written procedures?

21 CFR 111.13(a) - (a) You must assign qualified personnel to supervise the manufacturing, packaging, labeling, or h...

21 CFR 111.13(b) - (b) Each supervisor whom you use must be qualified by education, training, or experience to super...

21 CFR 111.16 - What are the requirements under this subpart C for written procedures?

21 CFR 111.15(i) - (i) Hand-washing facilities. You must provide hand-washing facilities that are designed to ensur...

21 CFR 111.15(h) - (h) Bathrooms. You must provide your employees with adequate, readily accessible bathrooms. The ...

21 CFR 111.15(k) - (k) Sanitation supervisors. You must assign one or more employees to supervise overall sanitatio...

21 CFR 111.15(j) - (j) Trash disposal. You must convey, store, and dispose of trash to:

21 CFR 111.15(f)(1) - (1) Carry sufficient amounts of water to required locations throughout the physical plant;

21 CFR 111.15(f)(2) - (2) Properly convey sewage and liquid disposable waste from your physical plant;

21 CFR 111.15(f)(3) - (3) Avoid being a source of contamination to components, dietary supplements, water supplies, or ...

21 CFR 111.15(f)(4) - (4) Provide adequate floor drainage in all areas where floors are subject to flooding-type cleani...

21 CFR 111.15(f)(5) - (5) Not allow backflow from, or cross connection between, piping systems that discharge waste wat...

21 CFR 111.15(e)(1) - (1) You must provide water that is safe and sanitary, at suitable temperatures, and under pressur...

21 CFR 111.15(e)(2) - (2) Water that is used in a manner such that the water may become a component of the dietary supp...

21 CFR 111.15(b)(1) - (1) You must maintain your physical plant in a clean and sanitary condition; and

21 CFR 111.15(b)(2) - (2) You must maintain your physical plant in repair sufficient to prevent components, dietary sup...

21 CFR 111.15(d)(1) - (1) You must not allow animals or pests in any area of your physical plant. Guard or guide dogs a...

21 CFR 111.15(d)(2) - (2) You must take effective measures to exclude pests from the physical plant and to protect agai...

21 CFR 111.15(d)(3) - (3) You must not use insecticides, fumigants, fungicides, or rodenticides, unless you take precau...

21 CFR 111.15(a) - (a) Grounds

21 CFR 111.15(a)(1) - (1) Properly storing equipment, removing litter and waste, and cutting weeds or grass within the ...

21 CFR 111.15(a)(2) - (2) Maintaining roads, yards, and parking lots so that they do not constitute a source of contami...

21 CFR 111.15(a)(3) - (3) Adequately draining areas that may contribute to the contamination of components, dietary sup...

21 CFR 111.15(a)(5) - (5) If your plant grounds are bordered by grounds not under your control, and if those other grou...

21 CFR 111.15(c)(1) - (1) You must use cleaning compounds and sanitizing agents that are free from microorganisms of pu...

21 CFR 111.15(c)(2) - (2) You must not use or hold toxic materials in a physical plant in which components, dietary sup...

21 CFR 111.15(c)(3) - (3) You must identify and hold cleaning compounds, sanitizing agents, pesticides, pesticide chemi...

21 CFR 111.20(a) - (a) Be suitable in size, construction, and design to facilitate maintenance, cleaning, and saniti...

21 CFR 111.20(h) - (h) Use adequate screening or other protection against pests, where necessary.

21 CFR 111.20(b) - (b) Have adequate space for the orderly placement of equipment and holding of materials as is nec...

21 CFR 111.20(f) - (f) Use safety-type light bulbs, fixtures, skylights, or other glass or glass-like materials when...

21 CFR 111.20(e)(1) - (1) All areas where components or dietary supplements are examined, processed, or held;

21 CFR 111.20(d) - (d) Be designed and constructed in a manner that prevents contamination of components, dietary su...

21 CFR 111.20(d)(2) - (2) When fans and other air-blowing equipment are used, such fans and equipment must be located a...

21 CFR 111.20(d)(1)(i) - (i) Floors, walls, and ceilings that can be adequately cleaned and kept clean and in good repair;

21 CFR 111.20(d)(1)(ii) - (ii) Fixtures, ducts, and pipes that do not contaminate components, dietary supplements, or conta...

21 CFR 111.20(d)(1)(iii) - (iii) Adequate ventilation or environmental control equipment such as airflow systems, including ...

21 CFR 111.20(d)(1)(iv) - (iv) Equipment that controls temperature and humidity, when such equipment is necessary to ensure...

21 CFR 111.20(d)(1)(v) - (v) Aisles or working spaces between equipment and walls that are adequately unobstructed and of ...

21 CFR 111.20(c) - (c) Permit the use of proper precautions to reduce the potential for mixups or contamination of c...

21 CFR 111.20(c)(1) - (1) Receiving, identifying, holding, and withholding from use, components, dietary supplements, p...

21 CFR 111.20(c)(2) - (2) Separating, as necessary, components, dietary supplements, packaging, and labels that are to ...

21 CFR 111.20(c)(3) - (3) Separating the manufacturing, packaging, labeling, and holding of different product types inc...

21 CFR 111.20(c)(5) - (5) Cleaning and sanitizing contact surfaces;

21 CFR 111.20(c)(7) - (7) Holding components or dietary supplements.

21 CFR 111.23(a) - (a) You must make and keep records required under this subpart C in accordance with subpart P of ...

21 CFR 111.23(c) - (c) You must make and keep records that show that water, when used in a manner such that the wate...

21 CFR 111.23(b) - (b) You must make and keep records of the written procedures for cleaning the physical plant and ...

21 CFR 111.35(a) - (a) You must make and keep records required under this subpart D in accordance with subpart P of ...

21 CFR 111.35(b)(2) - (2) Documentation, in individual equipment logs, of the date of the use, maintenance, cleaning, a...

21 CFR 111.35(b)(3) - (3) Documentation of any calibration, each time the calibration is performed, for instruments and...

21 CFR 111.35(b)(4) - (4) Written records of calibrations, inspections, and checks of automated, mechanical, and electr...

21 CFR 111.35(b)(5) - (5) Backup file(s) of current software programs (and of outdated software that is necessary to re...

21 CFR 111.35(b)(6) - (6) Documentation of the controls that you use to ensure that equipment functions in accordance w...

21 CFR 111.35(b)(1) - (1) Written procedures for fulfilling the requirements of this subpart, including written procedu...

21 CFR 111.35(b)(1)(i) - (i) Calibrating instruments and controls that you use in manufacturing or testing a component or ...

21 CFR 111.35(b)(1)(ii) - (ii) Calibrating, inspecting, and checking automated, mechanical, and electronic equipment; and

21 CFR 111.35(b)(1)(iii) - (iii) Maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other...

21 CFR 111.30(d) - (d) Establish and use appropriate controls for automated, mechanical, and electronic equipment (i...

21 CFR 111.30(c) - (c) Routinely calibrate, inspect, or check the equipment to ensure proper performance. Your quali...

21 CFR 111.30(a) - (a) Design or select equipment to ensure that dietary supplement specifications are consistently ...

21 CFR 111.30(e) - (e) Establish and use appropriate controls to ensure that the equipment functions in accordance w...

21 CFR 111.30(b) - (b) Determine the suitability of the equipment by ensuring that your equipment is capable of oper...

21 CFR 111.27(b) - (b) You must calibrate instruments and controls you use in manufacturing or testing a component o...

21 CFR 111.27(d) - (d) You must maintain, clean, and sanitize, as necessary, all equipment, utensils, and any other ...

21 CFR 111.27(d)(1) - (1) Equipment and utensils must be taken apart as necessary for thorough maintenance, cleaning, a...

21 CFR 111.27(d)(2) - (2) You must ensure that all contact surfaces, used for manufacturing or holding low-moisture com...

21 CFR 111.27(d)(3) - (3) If you use wet processing during manufacturing, you must clean and sanitize all contact surfa...

21 CFR 111.27(d)(4) - (4) You must clean surfaces that do not come into direct contact with components or dietary suppl...

21 CFR 111.27(d)(6) - (6) Cleaning compounds and sanitizing agents must be adequate for their intended use and safe und...

21 CFR 111.27(d)(7) - (7) You must store cleaned and sanitized portable equipment and utensils that have contact surfac...

21 CFR 111.27(a) - (a) You must use equipment and utensils that are of appropriate design, construction, and workman...

21 CFR 111.27(a)(2) - (2) You must use equipment and utensils of appropriate design and construction so that use will n...

21 CFR 111.27(a)(4) - (4) Equipment and utensils you use must have seams that are smoothly bonded or maintained to mini...

21 CFR 111.27(a)(6) - (6) Instruments or controls used in the manufacturing, packaging, labeling, or holding of a dieta...

21 CFR 111.27(a)(7) - (7) Compressed air or other gases you introduce mechanically into or onto a component, dietary su...

21 CFR 111.27(a)(3)(i) - (i) Installed and maintained to facilitate cleaning the equipment, utensils, and all adjacent spa...

21 CFR 111.27(a)(3)(ii) - (ii) Corrosion-resistant if the equipment or utensils contact components or dietary supplements;

21 CFR 111.27(a)(3)(iii) - (iii) Made of nontoxic materials;

21 CFR 111.27(a)(3)(iv) - (iv) Designed and constructed to withstand the environment in which they are used, the action of ...

21 CFR 111.27(a)(3)(v) - (v) Maintained to protect components and dietary supplements from being contaminated by any sourc...

21 CFR 111.27(a)(5)(i) - (i) Must be fitted with an indicating thermometer, temperature-measuring device, or temperature-r...

21 CFR 111.27(a)(5)(ii) - (ii) Must have an automated device for regulating temperature or an automated alarm system to ind...

21 CFR 111.25(a) - (a) Calibrating instruments and controls that you use in manufacturing or testing a component or ...

21 CFR 111.25(c) - (c) Maintaining, cleaning, and sanitizing, as necessary, all equipment, utensils, and any other c...

21 CFR 111.25(b) - (b) Calibrating, inspecting, and checking automated, mechanical, and electronic equipment; and

21 CFR 111.25 - What are the requirements under this subpart D for written procedures?

21 CFR 111.75(g) - (g) You must, at a minimum, conduct a visual examination of the packaging and labeling of the fin...

21 CFR 111.75(i) - (i) You must establish corrective action plans for use when an established specification is not m...

21 CFR 111.75(e) - (e) Before you package or label a product that you receive for packaging or labeling as a dietary...

21 CFR 111.75(d)(1) - (1) You may exempt one or more product specifications from verification requirements in paragraph...

21 CFR 111.75(d)(2) - (2) Your quality control personnel must review and approve the documentation that you provide und...

21 CFR 111.75(a)(1)(i) - (i) Conduct at least one appropriate test or examination to verify the identity of any component ...

21 CFR 111.75(a)(2) - (2) Confirm the identity of other components and determine whether other applicable component spe...

21 CFR 111.75(a)(2)(ii)(A) - (A) You first qualify the supplier by establishing the reliability of the supplier's certificate ...

21 CFR 111.75(a)(2)(ii)(B) - (B) The certificate of analysis includes a description of the test or examination method(s) used,...

21 CFR 111.75(a)(2)(ii)(C) - (C) You maintain documentation of how you qualified the supplier;

21 CFR 111.75(a)(2)(ii)(D) - (D) You periodically re-confirm the supplier's certificate of analysis; and

21 CFR 111.75(a)(2)(ii)(E) - (E) Your quality control personnel review and approve the documentation setting forth the basis f...

21 CFR 111.75(c) - (c) For a subset of finished dietary supplement batches that you identify through a sound statist...

21 CFR 111.75(c)(1) - (1) You must select one or more established specifications for identity, purity, strength, compos...

21 CFR 111.75(c)(2) - (2) You must conduct appropriate tests or examinations to determine compliance with the specifica...

21 CFR 111.75(c)(3) - (3) You must provide adequate documentation of your basis for determining that compliance with th...

21 CFR 111.75(c)(4) - (4) Your quality control personnel must review and approve the documentation that you provide und...

21 CFR 111.75(h) - (h)

21 CFR 111.75(h)(2) - (2) The tests and examinations that you use must include at least one of the following:

21 CFR 111.75(b)(1) - (1) Determine whether the in-process specifications are met; and

21 CFR 111.75(b)(2) - (2) Detect any deviation or unanticipated occurrence that may result in a failure to meet specifi...

21 CFR 111.75(f)(1) - (1) Before you use packaging, you must, at a minimum, conduct a visual identification of the cont...

21 CFR 111.75(f)(2) - (2) Before you use labels, you must, at a minimum, conduct a visual examination of the label and ...

21 CFR 111.70(f) - (f) If you receive a product from a supplier for packaging or labeling as a dietary supplement (a...

21 CFR 111.70(g) - (g) You must establish specifications for the packaging and labeling of the finished packaged and...

21 CFR 111.70(a) - (a) You must establish a specification for any point, step, or stage in the manufacturing process...

21 CFR 111.70(e) - (e) For each dietary supplement that you manufacture you must establish product specifications fo...

21 CFR 111.70(d) - (d) You must establish specifications for dietary supplement labels (label specifications) and fo...

21 CFR 111.70(c)(1) - (1) You must establish in-process specifications for any point, step, or stage in the master manu...

21 CFR 111.70(c)(2) - (2) You must provide adequate documentation of your basis for why meeting the in-process specific...

21 CFR 111.70(c)(3) - (3) Quality control personnel must review and approve the documentation that you provide under pa...

21 CFR 111.70(b) - (b) For each component that you use in the manufacture of a dietary supplement, you must establis...

21 CFR 111.70(b)(1) - (1) You must establish an identity specification;

21 CFR 111.70(b)(2) - (2) You must establish component specifications that are necessary to ensure that specifications ...

21 CFR 111.70(b)(3) - (3) You must establish limits on those types of contamination that may adulterate or may lead to ...

21 CFR 111.90(c) - (c) Any batch of dietary supplement that is reprocessed, that contains components that you have t...

21 CFR 111.90(b)(1) - (1) Quality control personnel conduct a material review and make a disposition decision that is b...

21 CFR 111.90(b)(2) - (2) The reprocessing, treatment or in-process adjustment is permitted by § 111.77;

21 CFR 111.90(a)(1) - (1) Quality control personnel conduct a material review and make a disposition decision to approv...

21 CFR 111.77(c) - (c) For specifications established under § 111.70(f) that you do not meet, quality control person...

21 CFR 111.77(b) - (b) For specifications established under § 111.70(b)(1) that you do not meet, quality control per...

21 CFR 111.77(a) - (a) For specifications established under § 111.70(a), (b)(2), (b)(3), (c), (d), (e), and (g) that...

21 CFR 111.87 - Who conducts a material review and makes a disposition decision?

21 CFR 111.73 - What is your responsibility for determining whether established specifications are met?

21 CFR 111.60(b) - (b) The production and in-process control system must include all requirements of subparts E thro...

21 CFR 111.60(a) - (a) Your production and in-process control system must be designed to ensure that the dietary sup...

21 CFR 111.95(a) - (a) You must make and keep records required under this subpart E in accordance with subpart P of ...

21 CFR 111.95(b)(1) - (1) The specifications established;

21 CFR 111.95(b)(2) - (2) Documentation of your qualification of a supplier for the purpose of relying on the supplier'...

21 CFR 111.95(b)(3) - (3) Documentation for why meeting in-process specifications, in combination with meeting componen...

21 CFR 111.95(b)(4) - (4) Documentation for why the results of appropriate tests or examinations for the product specif...

21 CFR 111.95(b)(5) - (5) Documentation for why any component and in-process testing, examination, or monitoring, and a...

21 CFR 111.65 - What are the requirements for quality control operations?

21 CFR 111.55 - What are the requirements to implement a production and process control system?

21 CFR 111.80(d) - (d) Representative samples of each unique shipment, and of each unique lot within each unique shi...

21 CFR 111.80(c) - (c) Representative samples of a subset of finished batches of each dietary supplement that you ma...

21 CFR 111.80(a) - (a) Representative samples of each unique lot of components, packaging, and labels that you use t...

21 CFR 111.80(b) - (b) Representative samples of in-process materials for each manufactured batch at points, steps, ...

21 CFR 111.80(e) - (e) Representative samples of each lot of packaged and labeled dietary supplements to determine w...

21 CFR 111.83(a) - (a) You must collect and hold reserve samples of each lot of packaged and labeled dietary supplem...

21 CFR 111.83(b)(1) - (1) Be held using the same container-closure system in which the packaged and labeled dietary sup...

21 CFR 111.83(b)(2) - (2) Be identified with the batch, lot, or control number;

21 CFR 111.83(b)(3) - (3) Be retained for 1 year past the shelf life date (if shelf life dating is used), or for 2 year...

21 CFR 111.83(b)(4) - (4) Consist of at least twice the quantity necessary for all tests or examinations to determine w...

21 CFR 111.135 - What quality control operations are required for product complaints?

21 CFR 111.120(b) - (b) Determining whether all components, packaging, and labels conform to specifications establish...

21 CFR 111.120(e) - (e) Approving, and releasing from quarantine, all components, packaging, and labels before they a...

21 CFR 111.120(c) - (c) Conducting any required material review and making any required disposition decision;

21 CFR 111.120 - What quality control operations are required for components, packaging, and labels before use in ...

21 CFR 111.105(g) - (g) Ensuring that required reserve samples are collected and held;

21 CFR 111.105(c) - (c) Reviewing and approving the documentation setting forth the basis for why meeting in-process ...

21 CFR 111.105(d) - (d) Reviewing and approving the documentation setting forth the basis for why the results of appr...

21 CFR 111.105(b) - (b) Reviewing and approving the documentation setting forth the basis for qualification of any su...

21 CFR 111.105(e) - (e) Reviewing and approving the basis and the documentation for why any product specification is ...

21 CFR 111.105(i) - (i) Performing other operations required under this subpart.

21 CFR 111.105(a) - (a) Approving or rejecting all processes, specifications, written procedures, controls, tests, an...

21 CFR 111.105(f) - (f) Ensuring that required representative samples are collected;

21 CFR 111.105(h) - (h) Determining whether all specifications established under § 111.70(a) are met; and

21 CFR 111.105 - What must quality control personnel do?

21 CFR 111.117(a) - (a) Reviewing and approving all processes for calibrating instruments and controls;

21 CFR 111.117(d) - (d) Reviewing and approving controls to ensure that automated, mechanical, or electronic equipmen...

21 CFR 111.117(b) - (b) Periodically reviewing all records for calibration of instruments and controls;

21 CFR 111.117(c) - (c) Periodically reviewing all records for calibrations, inspections, and checks of automated, me...

21 CFR 111.117 - What quality control operations are required for equipment, instruments, and controls?

21 CFR 111.127(f) - (f) Approving or rejecting any repackaging of a packaged dietary supplement;

21 CFR 111.127(b) - (b) Approving, and releasing from quarantine, all products that you receive for packaging or labe...

21 CFR 111.127(c) - (c) Reviewing and approving all records for packaging and label operations;

21 CFR 111.127(a) - (a) Reviewing the results of any visual examination and documentation to ensure that specificatio...

21 CFR 111.127(d) - (d) Determining whether the finished packaged and labeled dietary supplement conforms to specific...

21 CFR 111.127(e) - (e) Conducting any required material review and making any required disposition decision;

21 CFR 111.127(g) - (g) Approving or rejecting any relabeling of a packaged and labeled dietary supplement; and

21 CFR 111.127(h) - (h) Approving for release, or rejecting, any packaged and labeled dietary supplement (including a...

21 CFR 111.127 - What quality control operations are required for packaging and labeling operations?

21 CFR 111.130(d) - (d) Determining whether the reprocessed dietary supplement meets product specifications and eithe...

21 CFR 111.130(b) - (b) Approving or rejecting any salvage and redistribution of any returned dietary supplement;

21 CFR 111.130 - What quality control operations are required for returned dietary supplements?

21 CFR 111.130(a) - (a) Conducting any required material review and making any required disposition decision; includi...

21 CFR 111.130(a)(2) - (2) Reviewing the results of any tests or examinations that are conducted to determine compliance...

21 CFR 111.113(c) - (c) The person who conducts a material review and makes the disposition decision must, at the tim...

21 CFR 111.113 - What quality control operations are required for a material review and disposition decision?

21 CFR 111.113(a)(1) - (1) A specification established in accordance with § 111.70 is not met;

21 CFR 111.113(a)(2) - (2) A batch deviates from the master manufacturing record, including when any step established in...

21 CFR 111.113(a)(3) - (3) There is any unanticipated occurrence during the manufacturing operations that adulterates or...

21 CFR 111.113(a)(4) - (4) Calibration of an instrument or control suggests a problem that may have resulted in a failur...

21 CFR 111.113(a)(5) - (5) A dietary supplement is returned.

21 CFR 111.113(b)(1) - (1) When there is a deviation or unanticipated occurrence during the production and in-process co...

21 CFR 111.113(b)(2) - (2) When a specification established in accordance with § 111.70 is not met, quality control pers...

21 CFR 111.103 - What are the requirements under this subpart F for written procedures?

21 CFR 111.123 - What quality control operations are required for the master manufacturing record, the batch produ...

21 CFR 111.123(b)(1) - (1) Any batch of dietary supplement for which any component in the batch does not meet its identi...

21 CFR 111.123(b)(2) - (2) Any batch of dietary supplement, including any reprocessed batch, that does not meet all prod...

21 CFR 111.123(b)(3) - (3) Any batch of dietary supplement, including any reprocessed batch, that has not been manufactu...

21 CFR 111.123(b)(4) - (4) Any product received from a supplier for packaging or labeling as a dietary supplement (and f...

21 CFR 111.123(a)(1) - (1) Reviewing and approving all master manufacturing records and all modifications to the master ...

21 CFR 111.123(a)(2) - (2) Reviewing and approving all batch production-related records;

21 CFR 111.123(a)(3) - (3) Reviewing all monitoring required under subpart E;

21 CFR 111.123(a)(4) - (4) Conducting any required material review and making any required disposition decision;

21 CFR 111.123(a)(5) - (5) Approving or rejecting any reprocessing;

21 CFR 111.123(a)(6) - (6) Determining whether all in-process specifications established in accordance with § 111.70(c) ...

21 CFR 111.123(a)(7) - (7) Determining whether each finished batch conforms to product specifications established in acc...

21 CFR 111.123(a)(8) - (8) Approving and releasing, or rejecting, each finished batch for distribution, including any re...

21 CFR 111.110(a) - (a) Reviewing and approving all laboratory control processes associated with the production and p...

21 CFR 111.110(c) - (c) Reviewing and approving the results of all tests and examinations required under § 111.75.

21 CFR 111.110(b) - (b) Ensuring that all tests and examinations required under § 111.75 are conducted; and

21 CFR 111.110 - What quality control operations are required for laboratory operations associated with the produc...

21 CFR 111.140(a) - (a) You must make and keep the records required under this subpart F in accordance with subpart P...

21 CFR 111.140(b)(1) - (1) Written procedures for the responsibilities of the quality control operations, including writ...

21 CFR 111.140(b)(2)(i) - (i) Date that the review, approval, or rejection was performed; and

21 CFR 111.140(b)(2)(ii) - (ii) Signature of the person performing the review, approval, or rejection; and

21 CFR 111.140(b)(3) - (3) Documentation of any material review and disposition decision and followup

21 CFR 111.140(b)(3)(iii) - (iii) Evaluation of whether or not the deviation or unanticipated occurrence has resulted in or c...

21 CFR 111.140(b)(3)(iv) - (iv) Identification of the action(s) taken to correct, and prevent a recurrence of, the deviation...

21 CFR 111.140(b)(3)(v) - (v) Explanation of what you did with the component, dietary supplement, packaging, or label;

21 CFR 111.140(b)(3)(vii) - (vii) The signature of the individual(s) designated to perform the quality control operation, who...

21 CFR 111.170 - What requirements apply to rejected components, packaging, and labels, and to rejected products t...

21 CFR 111.180(a) - (a) You must make and keep records required under this subpart G in accordance with subpart P of ...

21 CFR 111.180(b)(1) - (1) Written procedures for fulfilling the requirements of this subpart.

21 CFR 111.180(b)(2) - (2) Receiving records (including records such as certificates of analysis, suppliers' invoices, a...

21 CFR 111.180(b)(3) - (3) Documentation that the requirements of this subpart were met

21 CFR 111.180(b)(3)(i) - (i) The person who performs the required operation must document, at the time of performance, tha...

21 CFR 111.180(b)(3)(ii)(A) - (A) The date that the components, packaging, labels, or products that you receive for packaging o...

21 CFR 111.180(b)(3)(ii)(B) - (B) The initials of the person performing the required operation;

21 CFR 111.180(b)(3)(ii)(C) - (C) The results of any tests or examinations conducted on components, packaging, or labels, and o...

21 CFR 111.180(b)(3)(ii)(D) - (D) Any material review and disposition decision conducted on components, packaging, labels, or p...

21 CFR 111.153 - What are the requirements under this subpart G for written procedures?

21 CFR 111.160(a) - (a) You must visually examine each immediate container or grouping of immediate containers in a s...

21 CFR 111.160(b) - (b) You must visually examine the supplier's invoice, guarantee, or certification in a shipment t...

21 CFR 111.160(e) - (e) You must hold packaging and labels under conditions that will protect against contamination a...

21 CFR 111.160(c) - (c) You must quarantine packaging and labels before you use them in the manufacture of a dietary ...

21 CFR 111.160(c)(1) - (1) You collect representative samples of each unique shipment, and of each unique lot within eac...

21 CFR 111.160(c)(2) - (2) Quality control personnel review and approve the results of any tests or examinations conduct...

21 CFR 111.160(c)(3) - (3) Quality control personnel approve the packaging and labels for use in the manufacture of a di...

21 CFR 111.160(d)(1) - (1) You must identify each unique lot within each unique shipment of packaging and labels in a ma...

21 CFR 111.160(d)(2) - (2) You must use this unique identifier whenever you record the disposition of each unique lot wi...

21 CFR 111.155(b) - (b) You must visually examine the supplier's invoice, guarantee, or certification in a shipment y...

21 CFR 111.155(e) - (e) You must hold components under conditions that will protect against contamination and deterio...

21 CFR 111.155(a) - (a) You must visually examine each immediate container or grouping of immediate containers in a s...

21 CFR 111.155(c) - (c) You must quarantine components before you use them in the manufacture of a dietary supplement...

21 CFR 111.155(c)(1) - (1) You collect representative samples of each unique lot of components (and, for components that...

21 CFR 111.155(c)(2) - (2) Quality control personnel review and approve the results of any tests or examinations conduct...

21 CFR 111.155(c)(3) - (3) Quality control personnel approve the components for use in the manufacture of a dietary supp...

21 CFR 111.155(d)(1) - (1) You must identify each unique lot within each unique shipment of components that you receive ...

21 CFR 111.155(d)(2) - (2) You must use this unique identifier whenever you record the disposition of each unique lot wi...

21 CFR 111.165(a) - (a) You must visually examine each immediate container or grouping of immediate containers in a s...

21 CFR 111.165(b) - (b) You must visually examine the supplier's invoice, guarantee, or certification in a shipment o...

21 CFR 111.165(e) - (e) You must hold the received product under conditions that will protect against contamination a...

21 CFR 111.165(d)(1) - (1) You must identify each unique lot within each unique shipment of received product in a manner...

21 CFR 111.165(d)(2) - (2) You must use this unique identifier whenever you record the disposition of each unique lot wi...

21 CFR 111.165(c) - (c) You must quarantine the received product until:

21 CFR 111.165(c)(1) - (1) You collect representative samples of each unique shipment, and of each unique lot within eac...

21 CFR 111.165(c)(2) - (2) Quality control personnel review and approve the documentation to determine whether the recei...

21 CFR 111.165(c)(3) - (3) Quality control personnel approve the received product for packaging or labeling as a dietary...

21 CFR 111.210(b) - (b) A complete list of components to be used;

21 CFR 111.210(a) - (a) The name of the dietary supplement to be manufactured and the strength, concentration, weight...

21 CFR 111.210(g) - (g) A description of packaging and a representative label, or a cross-reference to the physical l...

21 CFR 111.210(c) - (c) An accurate statement of the weight or measure of each component to be used;

21 CFR 111.210(e) - (e) A statement of any intentional overage amount of a dietary ingredient;

21 CFR 111.210(d) - (d) The identity and weight or measure of each dietary ingredient that will be declared on the Su...

21 CFR 111.210(f) - (f) A statement of theoretical yield of a manufactured dietary supplement expected at each point,...

21 CFR 111.210(h)(1) - (1) Specifications for each point, step, or stage in the manufacturing process where control is n...

21 CFR 111.210(h)(2) - (2) Procedures for sampling and a cross-reference to procedures for tests or examinations;

21 CFR 111.210(h)(4) - (4) Special notations and precautions to be followed; and

21 CFR 111.210(h)(5) - (5) Corrective action plans for use when a specification is not met.

21 CFR 111.210(h)(3) - (3) Specific actions necessary to perform and verify points, steps, or stages in the manufacturin...

21 CFR 111.210(h)(3)(i) - (i) Such specific actions must include verifying the weight or measure of any component and verif...

21 CFR 111.210(h)(3)(ii)(A) - (A) One person weighing or measuring a component and another person verifying the weight or measu...

21 CFR 111.210(h)(3)(ii)(B) - (B) One person adding the component and another person verifying the addition.

21 CFR 111.205(a) - (a) You must prepare and follow a written master manufacturing record for each unique formulation...

21 CFR 111.205(c) - (c) You must make and keep master manufacturing records in accordance with subpart P of this part...

21 CFR 111.205(b)(1) - (1) Identify specifications for the points, steps, or stages in the manufacturing process where c...

21 CFR 111.205(b)(2) - (2) Establish controls and procedures to ensure that each batch of dietary supplement that you ma...

21 CFR 111.260(d) - (d) The unique identifier that you assigned to each component (or, when applicable, to a product ...

21 CFR 111.260(h) - (h) The results of any testing or examination performed during the batch production, or a cross-r...

21 CFR 111.260(c) - (c) The date and time of the maintenance, cleaning, and sanitizing of the equipment and processin...

21 CFR 111.260(f) - (f) A statement of the actual yield and a statement of the percentage of theoretical yield at app...

21 CFR 111.260(e) - (e) The identity and weight or measure of each component used;

21 CFR 111.260(m) - (m) Documentation at the time of performance of any required material review and disposition deci...

21 CFR 111.260(n) - (n) Documentation at the time of performance of any reprocessing.

21 CFR 111.260(g) - (g) The actual results obtained during any monitoring operation;

21 CFR 111.260(b) - (b) The identity of equipment and processing lines used in producing the batch;

21 CFR 111.260(i) - (i) Documentation that the finished dietary supplement meets specifications established in accord...

21 CFR 111.260(k) - (k) Documentation, at the time of performance, of packaging and labeling operations, including:

21 CFR 111.260(k)(1) - (1) The unique identifier that you assigned to packaging and labels used, the quantity of the pac...

21 CFR 111.260(k)(2) - (2) An actual or representative label, or a cross-reference to the physical location of the actua...

21 CFR 111.260(k)(3) - (3) The results of any tests or examinations conducted on packaged and labeled dietary supplement...

21 CFR 111.260(l)(2) - (2) Approved or rejected any reprocessing or repackaging; and

21 CFR 111.260(l)(3) - (3) Approved and released, or rejected, the batch for distribution, including any reprocessed bat...

21 CFR 111.260(l)(4) - (4) Approved and released, or rejected, the packaged and labeled dietary supplement, including an...

21 CFR 111.260(l)(1) - (1) Reviewed the batch production record, including:

21 CFR 111.260(l)(1)(i) - (i) Review of any monitoring operation required under subpart E of this part; and

21 CFR 111.260(l)(1)(ii) - (ii) Review of the results of any tests and examinations, including tests and examinations conduc...

21 CFR 111.260(a)(1) - (1) Of the finished batch of dietary supplement; and

21 CFR 111.260(a)(2)(i) - (i) Each lot of packaged and labeled dietary supplement from the finished batch of dietary supple...

21 CFR 111.260(a)(2)(ii) - (ii) Each lot of dietary supplement, from the finished batch of dietary supplement, that you dist...

21 CFR 111.260(j) - (j) Documentation, at the time of performance, of the manufacture of the batch, including:

21 CFR 111.260(j)(1) - (1) The date on which each step of the master manufacturing record was performed; and

21 CFR 111.260(j)(2) - (2) The initials of the persons performing each step, including:

21 CFR 111.260(j)(2)(i) - (i) The initials of the person responsible for weighing or measuring each component used in the b...

21 CFR 111.260(j)(2)(ii) - (ii) The initials of the person responsible for verifying the weight or measure of each component...

21 CFR 111.260(j)(2)(iii) - (iii) The initials of the person responsible for adding the component to the batch; and

21 CFR 111.260(j)(2)(iv) - (iv) The initials of the person responsible for verifying the addition of components to the batch...

21 CFR 111.255(d) - (d) You must make and keep batch production records in accordance with subpart P of this part.

21 CFR 111.255(a) - (a) You must prepare a batch production record every time you manufacture a batch of a dietary su...

21 CFR 111.255(b) - (b) Your batch production record must include complete information relating to the production and...

21 CFR 111.255(c) - (c) Your batch production record must accurately follow the appropriate master manufacturing reco...

21 CFR 111.320(a) - (a) You must verify that the laboratory examination and testing methodologies are appropriate for...

21 CFR 111.320(b) - (b) You must identify and use an appropriate scientifically valid method for each established spe...

21 CFR 111.325(a) - (a) You must make and keep records required under this subpart J in accordance with subpart P of ...

21 CFR 111.325(b)(2) - (2) Documentation that laboratory methodology established in accordance with this subpart J is fo...

21 CFR 111.325(b)(2)(i) - (i) The person who conducts the testing and examination must document, at the time of performance...

21 CFR 111.325(b)(2)(ii) - (ii) The documentation for laboratory tests and examinations must include the results of the test...

21 CFR 111.315(d) - (d) Use of criteria for selecting standard reference materials used in performing tests and exami...

21 CFR 111.315(a) - (a) Use of criteria for establishing appropriate specifications;

21 CFR 111.315(c) - (c) Use of criteria for selecting appropriate examination and testing methods;

21 CFR 111.315(e) - (e) Use of test methods and examinations in accordance with established criteria.

21 CFR 111.315 - What are the requirements for laboratory control processes?

21 CFR 111.315(b) - (b) Use of sampling plans for obtaining representative samples, in accordance with subpart E of t...

21 CFR 111.315(b)(1) - (1) Components, packaging, and labels;

21 CFR 111.315(b)(2) - (2) In-process materials;

21 CFR 111.315(b)(3) - (3) Finished batches of dietary supplements;

21 CFR 111.315(b)(4) - (4) Product that you receive for packaging or labeling as a dietary supplement (and for distribut...

21 CFR 111.315(b)(5) - (5) Packaged and labeled dietary supplements.

21 CFR 111.310(c) - (c) Dietary supplements that you manufacture meet specifications.

21 CFR 111.303 - What are the requirements under this subpart J for written procedures?

21 CFR 111.360 - What are the requirements for sanitation?

21 CFR 111.353 - What are the requirements under this subpart K for written procedures?

21 CFR 111.370 - What requirements apply to rejected dietary supplements?

21 CFR 111.375(a) - (a) You must make and keep records required under this subpart K in accordance with subpart P of ...

21 CFR 111.375(b) - (b) You must make and keep records of the written procedures for manufacturing operations.

21 CFR 111.355 - What are the design requirements for manufacturing operations?

21 CFR 111.365(k) - (k) Identifying all processing lines and major equipment used during manufacturing to indicate th...

21 CFR 111.365(f) - (f) Holding components and dietary supplements that can support the rapid growth of microorganism...

21 CFR 111.365(i) - (i) Using effective measures to protect against the inclusion of metal or other foreign material ...

21 CFR 111.365(d) - (d) Performing chemical, microbiological, or other testing, as necessary to prevent the use of co...

21 CFR 111.365(a) - (a) Performing manufacturing operations under conditions and controls that protect against the po...

21 CFR 111.365(j) - (j) Segregating and identifying all containers for a specific batch of dietary supplements to ide...

21 CFR 111.365(e) - (e) Sterilizing, pasteurizing, freezing, refrigerating, controlling hydrogen-ion concentration (p...

21 CFR 111.365(c) - (c) Using water that, at a minimum, complies with the applicable Federal, State, and local requir...

21 CFR 111.365(g) - (g) Identifying and holding any components or dietary supplements, for which a material review an...

21 CFR 111.365(h) - (h) Performing mechanical manufacturing steps (such as cutting, sorting, inspecting, shredding, d...

21 CFR 111.365 - What precautions must you take to prevent contamination?

21 CFR 111.430(a) - (a) You must make and keep records required under this subpart L in accordance with subpart P of ...

21 CFR 111.430(b) - (b) You must make and keep records of the written procedures for packaging and labeling operation...

21 CFR 111.420(c) - (c) Quality control personnel must approve or reject each batch of repackaged or relabeled dietar...

21 CFR 111.420(b) - (b) You must examine a representative sample of each batch of repackaged or relabeled dietary sup...

21 CFR 111.420(a) - (a) You may repackage or relabel dietary supplements only after quality control personnel have ap...

21 CFR 111.410(c) - (c) You must examine, before packaging and labeling operations, packaging and labels for each bat...

21 CFR 111.410(d) - (d) You must be able to determine the complete manufacturing history and control of the packaged ...

21 CFR 111.410(a) - (a) You must take necessary actions to determine whether packaging for dietary supplements meets ...

21 CFR 111.410(b) - (b) You must control the issuance and use of packaging and labels and reconciliation of any issua...

21 CFR 111.425 - What requirements apply to a packaged and labeled dietary supplement that is rejected for distrib...

21 CFR 111.415(d) - (d) Establishing physical or spatial separation of packaging and label operations from operations...

21 CFR 111.415(b) - (b) Protecting manufactured dietary supplements from contamination, particularly airborne contami...

21 CFR 111.415(a) - (a) Cleaning and sanitizing all filling and packaging equipment, utensils, and dietary supplement...

21 CFR 111.415(h) - (h) Suitably disposing of labels and packaging for dietary supplements that are obsolete or incor...

21 CFR 111.415(g) - (g) Examining a representative sample of each batch of the packaged and labeled dietary supplemen...

21 CFR 111.415(c) - (c) Using sanitary handling procedures;

21 CFR 111.415(e) - (e) Identifying, by any effective means, filled dietary supplement containers that are set aside ...

21 CFR 111.415 - What requirements apply to filling, assembling, packaging, labeling, and related operations?

21 CFR 111.415(f)(1) - (1) Each lot of packaged and labeled dietary supplement from a finished batch of dietary suppleme...

21 CFR 111.403 - What are the requirements under this subpart L for written procedures?

21 CFR 111.475(a) - (a) You must make and keep records required under this subpart M in accordance with subpart P of ...

21 CFR 111.475(b)(1) - (1) Written procedures for holding and distributing operations; and

21 CFR 111.475(b)(2) - (2) Records of product distribution.

21 CFR 111.453 - What are the requirements under this subpart for M written procedures?

21 CFR 111.465(b) - (b) You must retain reserve samples for 1 year past the shelf life date (if shelf life dating is ...

21 CFR 111.465(a) - (a) You must hold reserve samples of dietary supplements in a manner that protects against contam...

21 CFR 111.465(a)(1) - (1) Holding the reserve samples under conditions consistent with product labels or, if no storage...

21 CFR 111.465(a)(2) - (2) Using the same container-closure system in which the packaged and labeled dietary supplement ...

21 CFR 111.470 - What requirements apply to distributing dietary supplements?

21 CFR 111.455(a) - (a) You must hold components and dietary supplements under appropriate conditions of temperature,...

21 CFR 111.455(c) - (c) You must hold components, dietary supplements, packaging, and labels under conditions that do...

21 CFR 111.455(b) - (b) You must hold packaging and labels under appropriate conditions so that the packaging and lab...

21 CFR 111.460(b) - (b) You must hold in-process material under appropriate conditions of temperature, humidity, and ...

21 CFR 111.460(a) - (a) You must identify and hold in-process material under conditions that protect against mixup, c...

21 CFR 111.510 - What requirements apply when a returned dietary supplement is received?

21 CFR 111.535(a) - (a) You must make and keep records required under this subpart N in accordance with subpart P of ...

21 CFR 111.535(b)(1) - (1) Written procedures for fulfilling the requirements of this subpart N.

21 CFR 111.535(b)(2) - (2) Any material review and disposition decision on a returned dietary supplement;

21 CFR 111.535(b)(3) - (3) The results of any testing or examination conducted to determine compliance with product spec...

21 CFR 111.535(b)(4) - (4) Documentation of the reevaluation by quality control personnel of any dietary supplement that...

21 CFR 111.525(a) - (a) You must ensure that any returned dietary supplements that are reprocessed meet all product s...

21 CFR 111.525(b) - (b) Quality control personnel must approve or reject the release for distribution of any returned...

21 CFR 111.530 - When must an investigation be conducted of your manufacturing processes and other batches?

21 CFR 111.503 - What are the requirements under this subpart N for written procedures?

21 CFR 111.520 - When may a returned dietary supplement be salvaged?

21 CFR 111.515 - When must a returned dietary supplement be destroyed, or otherwise suitably disposed of?

21 CFR 111.560(b) - (b) Quality control personnel must review and approve decisions about whether to investigate a pr...

21 CFR 111.560(c) - (c) The review and investigation of the product complaint by a qualified person, and the review b...

21 CFR 111.560(a)(1) - (1) Review all product complaints to determine whether the product complaint involves a possible ...

21 CFR 111.560(a)(2) - (2) Investigate any product complaint that involves a possible failure of a dietary supplement to...

21 CFR 111.553 - What are the requirements under this subpart O for written procedures?

21 CFR 111.570(a) - (a) You must make and keep the records required under this subpart O in accordance with subpart P...

21 CFR 111.570(b)(1) - (1) Written procedures for fulfilling the requirements of this subpart,

21 CFR 111.570(b)(2) - (2) A written record of every product complaint that is related to good manufacturing practice,

21 CFR 111.570(b)(2)(i) - (i) The person who performs the requirements of this subpart must document, at the time of perfor...

21 CFR 111.570(b)(2)(ii)(A) - (A) The name and description of the dietary supplement;

21 CFR 111.570(b)(2)(ii)(B) - (B) The batch, lot, or control number of the dietary supplement, if available;

21 CFR 111.570(b)(2)(ii)(C) - (C) The date the complaint was received and the name, address, or telephone number of the complai...

21 CFR 111.570(b)(2)(ii)(D) - (D) The nature of the complaint including, if known, how the product was used;

21 CFR 111.570(b)(2)(ii)(E) - (E) The reply to the complainant, if any; and

21 CFR 111.570(b)(2)(ii)(F) - (F) Findings of the investigation and followup action taken when an investigation is performed.

21 CFR 111.605(b) - (b) Records must be kept as original records, as true copies (such as photocopies, microfilm, mic...

21 CFR 111.605(c) - (c) All electronic records must comply with part 11 of this chapter.

21 CFR 111.605 - What requirements apply to the records that you make and keep?

21 CFR 111.610(a) - (a) You must have all records required under this part, or copies of such records, readily availa...

21 CFR 112.11 - What general requirements apply to persons who are subject to this part?

21 CFR 112.30(b) - (b) You must establish and keep records of training that document required training of personnel,...

21 CFR 112.22(b) - (b) Persons who conduct harvest activities for covered produce must also receive training that in...

21 CFR 112.22(a) - (a) At a minimum, all personnel who handle (contact) covered produce during covered activities or...

21 CFR 112.22(c) - (c) At least one supervisor or responsible party for your farm must have successfully completed f...

21 CFR 112.21(a) - (a) All personnel (including temporary, part time, seasonal, and contracted personnel) who handle...

21 CFR 112.21(b) - (b) All personnel (including temporary, part time, seasonal, and contracted personnel) who handle...

21 CFR 112.23 - What requirements apply regarding supervisors?

21 CFR 112.31 - What measures must I take to prevent ill or infected persons from contaminating covered produce w...

21 CFR 112.33(b) - (b) You must make toilet and hand-washing facilities accessible to visitors.

21 CFR 112.33(a) - (a) You must make visitors aware of policies and procedures to protect covered produce and food c...

21 CFR 112.32 - What hygienic practices must personnel use?

21 CFR 112.48(a) - (a) You must manage the water as necessary, including by establishing and following water-change ...

21 CFR 112.48(b) - (b) You must visually monitor the quality of water that you use during harvest, packing, and hold...

21 CFR 112.42(b) - (b) You must adequately maintain all agricultural water distribution systems to the extent they a...

21 CFR 112.42(a) - (a) At the beginning of a growing season, as appropriate, but at least once annually, you must in...

21 CFR 112.42(c) - (c) You must adequately maintain all agricultural water sources to the extent they are under your...

21 CFR 112.50(b) - (b) You must establish and keep the following records:

21 CFR 112.44(a) - (a) When you use agricultural water for any one or more of these following purposes, you must ens...

21 CFR 112.43(b) - (b) You must monitor any treatment of agricultural water at a frequency adequate to ensure that t...

21 CFR 112.43(a)(2) - (2) You must deliver any treatment of agricultural water in a manner to ensure that the treated w...

21 CFR 112.46(b) - (b) Except as provided in paragraph (a) of this section, you must take the following steps for ea...

21 CFR 112.46(c) - (c) If you use untreated ground water for the purposes that are subject to the requirements of § ...

21 CFR 112.83(b)(1) - (1) Assess the relevant areas used for a covered activity for evidence of potential contamination...

21 CFR 112.115 - What measures must I take when packaging covered produce?

21 CFR 112.112 - What measures must I take immediately prior to and during harvest activities?

21 CFR 112.114 - What requirements apply to dropped covered produce?

21 CFR 112.116(a) - (a) You must use food-packing material that is adequate for its intended use, which includes bein...

21 CFR 112.116(b) - (b) If you reuse food-packing material, you must take adequate steps to ensure that food contact ...

21 CFR 112.113 - How must I handle harvested covered produce during covered activities?

21 CFR 112.132(b) - (b) You must adequately operate systems for waste treatment and disposal so that they do not cons...

21 CFR 112.132(a) - (a) You must convey, store, and dispose of trash, litter and waste to:

21 CFR 112.133 - What requirements apply to plumbing?

21 CFR 112.128(b) - (b) For fully-enclosed buildings, you must take measures to exclude pests from your buildings.

21 CFR 112.128(a) - (a) You must take those measures reasonably necessary to protect covered produce, food contact su...

21 CFR 112.128(c) - (c) For partially-enclosed buildings, you must take measures to prevent pests from becoming estab...

21 CFR 112.126(b) - (b) You must implement measures to prevent contamination of your covered produce and food contact...

21 CFR 112.126(a)(1) - (1) Buildings must be suitable in size, construction, and design to facilitate maintenance and sa...

21 CFR 112.126(a)(2) - (2) You must provide adequate drainage in all areas where normal operations release or discharge ...

21 CFR 112.140(b) - (b) You must establish and keep documentation of the date and method of cleaning and sanitizing o...

21 CFR 112.123(e) - (e) If you use equipment such as pallets, forklifts, tractors, and vehicles such that they are in...

21 CFR 112.123(a) - (a) You must use equipment and tools that are of adequate design, construction, and workmanship t...

21 CFR 112.123(d)(1) - (1) You must inspect, maintain, and clean and, when necessary and appropriate, sanitize all food ...

21 CFR 112.123(d)(2) - (2) You must maintain and clean all non-food-contact surfaces of equipment and tools subject to t...

21 CFR 112.123(b)(1) - (1) Installed and maintained as to facilitate cleaning of the equipment and of all adjacent space...

21 CFR 112.123(b)(2) - (2) Stored and maintained to protect covered produce from being contaminated with known or reason...

21 CFR 112.129(a) - (a) You must provide personnel with adequate, readily accessible toilet facilities, including toi...

21 CFR 112.129(b) - (b) Your toilet facilities must be designed, located, and maintained to:

21 CFR 112.129(b)(2) - (2) Be directly accessible for servicing, be serviced and cleaned at a frequency sufficient to en...

21 CFR 112.130(c) - (c) You must provide for appropriate disposal of waste (for example, waste water and used single-...

21 CFR 112.130(b) - (b) Your hand-washing facilities must be furnished with:

21 CFR 112.130(a) - (a) You must provide personnel with adequate, readily accessible hand-washing facilities during g...

21 CFR 112.134(a) - (a) If you have domesticated animals, to prevent contamination of covered produce, food contact s...

21 CFR 112.127(a)(1) - (1) Excluding domesticated animals from fully-enclosed buildings where covered produce, food cont...

21 CFR 112.124 - What requirements apply to instruments and controls used to measure, regulate, or record?

21 CFR 112.125 - What requirements apply to equipment that is subject to this subpart used in the transport of cov...

21 CFR 112.150(b)(1) - (1) Documentation of your treatment of seeds or beans to reduce microorganisms of public health s...

21 CFR 112.150(b)(4) - (4) Documentation of the results of all analytical tests conducted for purposes of compliance wit...

21 CFR 112.150(b)(6) - (6) Documentation of actions you take in accordance with §§ 112.142(b) and (c), 112.146, and 112....

21 CFR 112.142(d) - (d) You must visually examine seeds and beans, and packaging used to ship seeds or beans, for sig...

21 CFR 112.142(a) - (a) You must take measures reasonably necessary to prevent the introduction of known or reasonabl...

21 CFR 112.142(b)(1) - (1) Discontinue use of all seeds or beans from that lot for sprout production and ensure that spr...

21 CFR 112.142(b)(2) - (2) Report the information (association with illness and/or findings of microbial testing) to the...

21 CFR 112.142(e)(1) - (1) Treat seeds or beans that will be used to grow sprouts using a scientifically valid method to...

21 CFR 112.144(a) - (a) You must test the growing, harvesting, packing, and holding environment for Listeria species ...

21 CFR 112.144(b)(1) - (1) Test spent sprout irrigation water from each production batch of sprouts for E. coli O157:H7,...

21 CFR 112.144(b)(2) - (2) If testing spent sprout irrigation water is not practicable (for example, soil-grown sprouts ...

21 CFR 112.147(c) - (c) Your written sampling plan must include a corrective action plan that at a minimum, requires ...

21 CFR 112.147(b) - (b) In accordance with the written sampling plan required under paragraph (a) of this section, yo...

21 CFR 112.147(a) - (a) You must establish and implement a written sampling plan that identifies the number and locat...

21 CFR 112.146(c) - (c) Conduct additional sampling and testing to determine whether the Listeria species or L. monoc...

21 CFR 112.146(a) - (a) Conduct additional testing of surfaces and areas surrounding the area where Listeria species ...

21 CFR 112.146(b) - (b) Clean and sanitize the affected surfaces and surrounding areas;

21 CFR 112.145(e) - (e) Your written environmental monitoring plan must include a corrective action plan that, at a m...

21 CFR 112.145(a) - (a) You must establish and implement a written environmental monitoring plan that is designed to ...

21 CFR 112.145(c) - (c) Your written environmental monitoring plan must include a sampling plan that specifies:

21 CFR 112.145(c)(3) - (3) Sample collection sites; the number and location of sampling sites must be sufficient to dete...

21 CFR 112.143(a) - (a) You must grow, harvest, pack, and hold sprouts in a fully-enclosed building.

21 CFR 112.143(b) - (b) Any food contact surfaces you use to grow, harvest, pack, or hold sprouts must be cleaned and...

21 CFR 112.152 - What methods must I use to test the growing, harvesting, packing, and holding environment for Lis...

21 CFR 112.153 - What methods must I use to test spent sprout irrigation water (or sprouts) from each production b...

21 CFR 112.151 - What methods must I use to test the quality of water to satisfy the requirements of § 112.46?

21 CFR 112.162 - Where must I store records?

21 CFR 112.161(a) - (a) Except as otherwise specified, all records required under this part must:

21 CFR 112.161(b) - (b) Records required under §§ 112.7(b), 112.30(b), 112.50(b)(2), (4), and (6), 112.60(b)(2), 112....

21 CFR 113.10 - Personnel.

21 CFR 113.40(j) - (j) Other systems. All systems, whether or not specifically mentioned in this part, for the ther...

21 CFR 113.40(i) - (i) Equipment and procedures for thermal processing of foods wherein critical factors such as wat...

21 CFR 113.40(d)(4) - (4) Steam controller. Each retort shall be equipped with an automatic steam controller to mainta...

21 CFR 113.40(d)(6) - (6) Venting and condensate removal. The air in each retort shall be removed before processing is...

21 CFR 113.40(d)(1) - (1) Temperature-indicating device

21 CFR 113.40(d)(1)(i) - (i) The design of the temperature-indicating device shall ensure that the accuracy of the device ...

21 CFR 113.40(d)(2) - (2) Temperature-recording device

21 CFR 113.40(d)(2)(iii) - (iii) Adjustments. The temperature-recording device shall be adjusted with sufficient frequency ...

21 CFR 113.40(f)(1) - (1) Temperature-indicating device. Each retort shall be equipped with at least one temperature-i...

21 CFR 113.40(f)(7) - (7) Bleeders. Bleeder openings 1⁄4-inch (6 millimeters) or larger shall be located at the top of...

21 CFR 113.40(f)(8) - (8) Retort speed. The speed of the container-conveyor chain shall be specified in the scheduled ...

21 CFR 113.40(f)(2)(iii) - (iii) Adjustments. The temperature-recording device shall be adjusted with sufficient frequency ...

21 CFR 113.40(f)(9)(iii) - (iii) Such measurements and recordings should be made at intervals not to exceed 15 minutes.

21 CFR 113.40(b)(10) - (10) Water level indicator. There shall be a means of determining the water level in the retort ...

21 CFR 113.40(b)(11) - (11) Water circulation. When a water circulating system is used for heat distribution, it shall ...

21 CFR 113.40(b)(14) - (14) Vertical and horizontal still retorts. Vertical and horizontal still retorts should follow ...

21 CFR 113.40(b)(4) - (4) Steam controller. Each retort shall be equipped with an automatic steam controller to mainta...

21 CFR 113.40(b)(5) - (5) Steam introduction. Steam shall be distributed in the bottom of the retort in a manner adequ...

21 CFR 113.40(b)(7) - (7) Stacking equipment and position of containers. Crates, trays, gondolas, etc., for holding co...

21 CFR 113.40(b)(8) - (8) Drain valve. A nonclogging, water-tight valve shall be used. A screen shall be installed or ...

21 CFR 113.40(b)(9) - (9) Air supply and controls. In both horizontal and vertical still retorts for pressure processi...

21 CFR 113.40(b)(1) - (1) Temperature-indicating device

21 CFR 113.40(b)(1)(ii) - (ii) Records of the accuracy of the temperature-indicating device and of a reference device that ...

21 CFR 113.40(b)(1)(iv) - (iv) A temperature-indicating device shall be accurate to 1 °F (0.5 °C). The temperature range of...

21 CFR 113.40(b)(1)(v) - (v) Each temperature-indicating device shall be installed where it can be accurately and easily r...

21 CFR 113.40(b)(15) - (15) Critical factors

21 CFR 113.40(b)(15)(i) - (i) When maximum fill-in or drained weight is specified in the scheduled process, it shall be mea...

21 CFR 113.40(b)(15)(iii) - (iii) Such measurements and recordings should be made at intervals not to exceed 15 minutes.

21 CFR 113.40(b)(15)(iv) - (iv) When the product style results in stratification or layering of the primary product in the c...

21 CFR 113.40(b)(2) - (2) Temperature-recording device

21 CFR 113.40(b)(2)(i) - (i) Analog or graphical recordings. Temperature-recording devices that create analog or graphica...

21 CFR 113.40(b)(2)(iii) - (iii) Adjustments. The temperature-recording device shall be adjusted with sufficient frequency ...

21 CFR 113.40(b)(2)(iv) - (iv) Temperature controller. The temperature-recording device may be combined with the steam con...

21 CFR 113.40(g)(4) - (4) Critical factors. Critical factors specified in the scheduled process shall be measured and ...

21 CFR 113.40(g)(1)(i)(C) - (C) Temperature controller. An accurate temperature controller shall be installed and capable of...

21 CFR 113.40(g)(1)(i)(E) - (E) Differential pressure recorder-controller. When a product-to-product regenerator is used, it...

21 CFR 113.40(g)(1)(i)(F) - (F) Flow control. A flow control device shall be located upstream from the holding tube and shal...

21 CFR 113.40(g)(1)(i)(G) - (G) Product holding tube. The product-sterilizing holding tube shall be designed to give continu...

21 CFR 113.40(g)(1)(i)(I) - (I) Equipment downstream from the holding tube. Product coolers, aseptic surge tanks, or any oth...

21 CFR 113.40(g)(1)(i)(A) - (A) Temperature-indicating device

21 CFR 113.40(g)(1)(i)(A)(1) - (1) The design of the temperature-indicating device shall ensure that the accuracy of the device ...

21 CFR 113.40(g)(1)(i)(A)(4) - (4) A temperature-indicating device shall be accurate to 1 °F (0.5 °C). The temperature range of ...

21 CFR 113.40(g)(1)(i)(A)(5) - (5) Each temperature-indicating device shall be installed where it can be accurately and easily r...

21 CFR 113.40(g)(1)(i)(B) - (B) Temperature-recording device

21 CFR 113.40(g)(1)(i)(B)(1) - (1) Analog or graphical recordings. Temperature-recording devices that create analog or graphica...

21 CFR 113.40(g)(1)(i)(B)(2) - (2) Digital recordings. Temperature-recording devices, such as data loggers, that record numbers...

21 CFR 113.40(g)(1)(i)(B)(3) - (3) Adjustments. The temperature-recording device shall be adjusted with sufficient frequency to...

21 CFR 113.40(g)(1)(ii)(A) - (A) Startup. Before the start of aseptic processing operations the product sterilizer and all pr...

21 CFR 113.40(g)(1)(ii)(B) - (B) Temperature drop in product-sterilizing holding tube. When product temperature in the holdin...

21 CFR 113.40(g)(1)(ii)(E) - (E) Records. Readings at the following points shall be observed and recorded at the start of ase...

21 CFR 113.40(g)(2)(i)(A) - (A) Recording device. The container and closure sterilization system and product filling and clo...

21 CFR 113.40(g)(2)(i)(B) - (B) Timing method(s). A method(s) shall be used either to give the retention time of containers,...

21 CFR 113.40(g)(2)(ii)(B) - (B) Loss of sterility. A system shall be provided to stop packaging operations, or alternatively...

21 CFR 113.40(g)(2)(ii)(C) - (C) Records. Observations and measurements of operating conditions shall be made and recorded at...

21 CFR 113.40(e)(5) - (5) Retort speed timing. The rotational speed of the retort shall be specified in the scheduled ...

21 CFR 113.40(e)(9) - (9) Critical factors. Critical factors specified in the scheduled process shall be measured and ...

21 CFR 113.40(e)(1) - (1) Temperature-indicating device

21 CFR 113.40(e)(1)(ii) - (ii) Records of the accuracy of the temperature-indicating device and of a reference device that ...

21 CFR 113.40(e)(1)(iv) - (iv) A temperature-indicating device shall be accurate to 1 °F (0.5 °C). The temperature range of...

21 CFR 113.40(e)(1)(v) - (v) Each temperature-indicating device shall be installed where it can be accurately and easily r...

21 CFR 113.40(e)(2) - (2) Temperature-recording device

21 CFR 113.40(e)(2)(i) - (i) Analog or graphical recordings. Temperature-recording devices that create analog or graphica...

21 CFR 113.40(e)(2)(iii) - (iii) Adjustments. The temperature-recording device shall be adjusted with sufficient frequency ...

21 CFR 113.40(e)(6) - (6) Air supply and controls

21 CFR 113.40(e)(6)(ii) - (ii) A water level indicator, e.g., sensor, gage, water glass, or petcock(s), shall be used for d...

21 CFR 113.40(c)(10) - (10) Critical factors. Critical factors specified in the scheduled process shall be measured and...

21 CFR 113.40(c)(5) - (5) Bleeders. Bleeders, except those for temperature-indicating device wells, shall be 1⁄8-inch ...

21 CFR 113.40(c)(6) - (6) Venting and condensate removal. Vents shall be located in that portion of the retort opposit...

21 CFR 113.40(c)(7) - (7) Retort speed timing. The rotational speed of the retort shall be specified in the scheduled ...

21 CFR 113.40(c)(9) - (9) Temperature drop. If the temperature of the continuous retort drops below the temperature sp...

21 CFR 113.40(c)(1)(ii) - (ii) Records of the accuracy of the temperature-indicating device and of a reference device that ...

21 CFR 113.40(c)(1)(iv) - (iv) A temperature-indicating device shall be accurate to 1 °F (0.5 °C). The temperature range of...

21 CFR 113.40(c)(1)(v) - (v) Each temperature-indicating device shall be installed where it can be accurately and easily r...

21 CFR 113.40(c)(2)(ii) - (ii) Digital recordings. Temperature-recording devices, such as data loggers, that record number...

21 CFR 113.40(c)(2)(iii) - (iii) Adjustments. The temperature-recording device shall be adjusted with sufficient frequency ...

21 CFR 113.40(c)(8)(i) - (i) Any containers in the retort intake valve or in transfer valves between cooker shells of a co...

21 CFR 113.40(c)(8)(ii) - (ii) Both the time at which the reel stopped and the time the retort was used for a still retort ...

21 CFR 113.40(a)(10) - (10) Air valves. Retorts using air for pressure cooling shall be equipped with a suitable valve ...

21 CFR 113.40(a)(11) - (11) Water valves. Retorts using water for cooling shall be equipped with a suitable valve to pr...

21 CFR 113.40(a)(4) - (4) Steam controller. Each retort shall be equipped with an automatic steam controller to mainta...

21 CFR 113.40(a)(5) - (5) Steam inlet. The steam inlet to each still retort shall be large enough to provide sufficien...

21 CFR 113.40(a)(6) - (6) Crate supports. A bottom crate support shall be used in vertical still retorts. Baffle plate...

21 CFR 113.40(a)(7) - (7) Steam spreaders. Steam spreaders are continuations of the steam inlet line inside the retort...

21 CFR 113.40(a)(8) - (8) Bleeders. Bleeders, except those for temperature-indicating device wells, shall be 1/8-inch ...

21 CFR 113.40(a)(9) - (9) Stacking equipment and position of containers. Crates, trays, gondolas, etc., for holding co...

21 CFR 113.40(a)(1) - (1) Temperature-indicating device

21 CFR 113.40(a)(1)(ii) - (ii) Records of the accuracy of the temperature-indicating device and of a reference device that ...

21 CFR 113.40(a)(1)(iii) - (iii) A temperature-indicating device that is defective or cannot be adjusted to the accurate cal...

21 CFR 113.40(a)(1)(iv) - (iv) A temperature-indicating device shall be accurate to 1 °F (0.5 °C). The temperature range of...

21 CFR 113.40(a)(1)(v) - (v) Each temperature-indicating device shall be installed where it can be accurately and easily r...

21 CFR 113.40(a)(12) - (12) Vents

21 CFR 113.40(a)(12)(iii) - (iii) Other procedures. Other installations and operating procedures that deviate from the requi...

21 CFR 113.40(a)(13) - (13) Critical factors

21 CFR 113.40(a)(13)(i) - (i) When maximum fill-in or drained weight is specified in the scheduled process, it shall be mea...

21 CFR 113.40(a)(13)(ii) - (ii) Closing machine vacuum in vacuum-packed products shall be observed and recorded at intervals...

21 CFR 113.40(a)(13)(iii) - (iii) Such measurements and recordings should be made at intervals not to exceed 15 minutes.

21 CFR 113.40(a)(13)(iv) - (iv) When the product style results in stratification or layering of the primary product in the c...

21 CFR 113.40(a)(2) - (2) Temperature-recording device

21 CFR 113.40(a)(2)(i) - (i) Analog or graphical recordings. Temperature-recording devices that create analog or graphica...

21 CFR 113.40(a)(2)(iii) - (iii) Adjustments. The temperature-recording device shall be adjusted with sufficient frequency ...

21 CFR 113.60(b) - (b) Cooling water. Container cooling water shall be chlorinated or otherwise sanitized as necess...

21 CFR 113.60(d) - (d) Postprocess handling. Container handling equipment used in handling filled containers shall ...

21 CFR 113.60(c) - (c) Coding. Each hermetically sealed container of low-acid processed food shall be marked with a...

21 CFR 113.60(a) - (a) Closures

21 CFR 113.60(a)(2) - (2) For glass containers with vacuum closures, capper efficiency must be checked by a measurement...

21 CFR 113.60(a)(3) - (3) For closures other than double seams and glass containers, appropriate detailed inspections a...

21 CFR 113.60(a)(1) - (1) Teardown examinations for double-seam cans shall be performed by a qualified individual and t...

21 CFR 113.60(a)(1)(ii) - (ii) Two measurements at different locations, excluding the side seam, shall be made for each dou...

21 CFR 113.60(a)(1)(i)(a) - (a) Micrometer measurement system:

21 CFR 113.60(a)(1)(i)(b) - (b) Seam scope or projector:

21 CFR 113.81(a) - (a) Before using raw materials and ingredients susceptible to microbiological contamination, the ...

21 CFR 113.81(b) - (b) Blanching by heat, when required in the preparation of food for canning, should be effected b...

21 CFR 113.81(f) - (f) When the scheduled process sets forth critical factors to prevent the growth of microorganism...

21 CFR 113.81(e) - (e) When the maintenance of pH (above 4.6) of a normally low-acid food is a basis for a scheduled...

21 CFR 113.81(c) - (c) The filling of containers, either mechanically or by hand, shall be controlled so as to ensur...

21 CFR 113.89 - Deviations in processing, venting, or control of critical factors.

21 CFR 113.83 - Establishing scheduled processes.

21 CFR 113.87(c) - (c) The initial temperature of the contents of the containers to be processed shall be accurately...

21 CFR 113.87(g) - (g) If mufflers are used on bleeders or vent systems, evidence that the bleeders or vents are ope...

21 CFR 113.87(a) - (a) Operating processes and retort venting procedures to be used for each product and container s...

21 CFR 113.87(d) - (d) Timing devices used in recording thermal process time information shall be accurate to the ex...

21 CFR 113.87(b) - (b) A system for product traffic control in the retort room shall be established to prevent unret...

21 CFR 113.87(f) - (f) The steam supply to the thermal processing system shall be adequate to the extent needed to e...

21 CFR 113.87(e) - (e) Clock times on temperature-recording device records shall reasonably correspond to the time o...

21 CFR 113.100(b) - (b) Temperature-recording device records shall be identified by date, retort number, and other da...

21 CFR 113.100(g) - (g) Copies of all records provided for in this part, except those required under § 113.83 establi...

21 CFR 113.100(e) - (e) Records of all container closure examinations shall specify the product code, the date and ti...

21 CFR 113.100(f) - (f) Records shall be maintained to identify the initial distribution of the finished product to f...

21 CFR 113.100(h) - (h) Records of this part may be maintained electronically, provided they are in compliance with p...

21 CFR 113.100(c)(1) - (1) A reference to the tag, seal, or other means of identity used by the processor to identify th...

21 CFR 113.100(c)(3) - (3) The identity of the reference device, equipment, and procedures used for the accuracy test an...

21 CFR 113.100(c)(6) - (6) The date on or before which the next accuracy test must be performed.

21 CFR 113.100(d)(3) - (3) The identity of the equipment and reference to procedures used for the accuracy test and to a...

21 CFR 113.100(d)(6) - (6) The date on or before which the next accuracy test must be performed.

21 CFR 113.100(a) - (a) Processing and production information shall be entered at the time it is observed by the reto...

21 CFR 113.100(a)(1) - (1) Still retorts. Time steam on; time temperature up to processing temperature; time steam off;...

21 CFR 113.100(a)(2) - (2) Agitating retorts. Functioning of condensate bleeder; retort speed; and, when specified in t...

21 CFR 113.100(a)(4) - (4) Aseptic processing and packaging systems. Product temperature in the holding tube outlet as ...

21 CFR 113.100(a)(6) - (6) Food preservation methods wherein critical factors such as water activity are used in conjunc...

21 CFR 113.100(a)(7) - (7) Other systems. Critical factors specified in the formulation of the product or in the schedu...

21 CFR 114.10 - Personnel.

21 CFR 114.83 - Establishing scheduled processes.

21 CFR 114.80(b) - (b) Coding. Each container or product shall be marked with an identifying code permanently visib...

21 CFR 114.80(a) - (a) Processing operations

21 CFR 114.80(a)(1) - (1) Acidified foods shall be so manufactured, processed, and packaged that a finished equilibrium...

21 CFR 114.80(a)(2) - (2) Sufficient control, including frequent testing and recording of results, shall be exercised s...

21 CFR 114.80(a)(4) - (4) Testing and examinations of containers shall occur often enough to ensure that the container ...

21 CFR 114.89 - Deviations from scheduled processes.

21 CFR 114.100(e) - (e) Copies of all records provided for in paragraphs (b), (c), and (d) of this section shall be r...

21 CFR 114.100(a) - (a) Records shall be maintained of examinations of raw materials, packaging materials, and finish...

21 CFR 114.100(b) - (b) Processing and production records showing adherence to scheduled processes, including records...

21 CFR 114.100(d) - (d) Records shall be maintained identifying initial distribution of the finished product to facil...

21 CFR 114.100(c) - (c) All departures from scheduled processes having a possible bearing on public health or the saf...

21 CFR 117.4 - Qualifications of individuals who manufacture, process, pack, or hold food.

21 CFR 117.37 - Sanitary facilities and controls.

21 CFR 117.80(a) - (a) General

21 CFR 117.80(a)(2) - (2) Appropriate quality control operations must be employed to ensure that food is suitable for h...

21 CFR 117.80(a)(5) - (5) Chemical, microbial, or extraneous-material testing procedures must be used where necessary t...

21 CFR 117.80(c) - (c) Manufacturing operations

21 CFR 117.80(c)(8) - (8) Adequate measures must be taken to protect against the inclusion of metal or other extraneous...

21 CFR 117.80(c)(9) - (9) Food, raw materials, and other ingredients that are adulterated:

21 CFR 117.80(b)(1) - (1) Raw materials and other ingredients must be inspected and segregated or otherwise handled as ...

21 CFR 117.80(b)(2) - (2) Raw materials and other ingredients must either not contain levels of microorganisms that may...

21 CFR 117.80(b)(3) - (3) Raw materials and other ingredients susceptible to contamination with aflatoxin or other natu...

21 CFR 117.80(b)(4) - (4) Raw materials, other ingredients, and rework susceptible to contamination with pests, undesir...

21 CFR 117.80(b)(5) - (5) Raw materials, other ingredients, and rework must be held in bulk, or in containers designed ...

21 CFR 117.80(b)(6) - (6) Frozen raw materials and other ingredients must be kept frozen. If thawing is required prior ...

21 CFR 117.80(b)(8) - (8) Raw materials and other ingredients that are food allergens, and rework that contains food al...

21 CFR 117.40(g) - (g) Compressed air or other gases mechanically introduced into food or used to clean food-contact...

21 CFR 117.40(f) - (f) Instruments and controls used for measuring, regulating, or recording temperatures, pH, acidi...

21 CFR 117.40(e) - (e) Each freezer and cold storage compartment used to store and hold food capable of supporting g...

21 CFR 117.40 - Equipment and utensils.

21 CFR 117.110 - Defect action levels.

21 CFR 117.93 - Warehousing and distribution.

21 CFR 117.10 - Personnel.

21 CFR 117.35(a) - (a) General maintenance. Buildings, fixtures, and other physical facilities of the plant must be...

21 CFR 117.35(d) - (d) Sanitation of food-contact surfaces. All food-contact surfaces, including utensils and food-...

21 CFR 117.35(e) - (e) Sanitation of non-food-contact surfaces. Non-food-contact surfaces of equipment used in the ...

21 CFR 117.35(c) - (c) Pest control. Pests must not be allowed in any area of a food plant. Guard, guide, or pest-d...

21 CFR 117.35(b)(1) - (1) Cleaning compounds and sanitizing agents used in cleaning and sanitizing procedures must be f...

21 CFR 117.35(b)(2) - (2) Toxic cleaning compounds, sanitizing agents, and pesticide chemicals must be identified, held...

21 CFR 117.95(a) - (a) Human food by-products held for distribution as animal food without additional manufacturing ...

21 CFR 117.95(a)(3) - (3) During holding, human food by-products for use as animal food must be accurately identified.

21 CFR 117.20(b) - (b) Plant construction and design. The plant must be suitable in size, construction, and design ...

21 CFR 117.20(a) - (a) Grounds. The grounds about a food plant under the control of the operator must be kept in a ...

21 CFR 117.170(d) - (d) You must revise the written food safety plan if a significant change in the activities conduc...

21 CFR 117.170(e) - (e) A preventive controls qualified individual must perform (or oversee) the reanalysis.

21 CFR 117.170 - Reanalysis.

21 CFR 117.160(a) - (a) You must validate that the preventive controls identified and implemented in accordance with ...

21 CFR 117.160(b) - (b) The validation of the preventive controls:

21 CFR 117.165(b) - (b) Written procedures. As appropriate to the facility, the food, the nature of the preventive c...

21 CFR 117.165(a)(4) - (4) Review of the following records within the specified timeframes, by (or under the oversight o...

21 CFR 117.145(a) - (a) Written procedures. You must establish and implement written procedures, including the frequ...

21 CFR 117.145(b) - (b) Monitoring. You must monitor the preventive controls with adequate frequency to provide assu...

21 CFR 117.145(c)(1) - (1) Requirement to document monitoring. You must document the monitoring of preventive controls ...

21 CFR 117.136(a)(2) - (2) You rely on your customer who is subject to the requirements for hazard analysis and risk-bas...

21 CFR 117.139(a) - (a) You must establish a written recall plan for the food.

21 CFR 117.139(b) - (b) The written recall plan must include procedures that describe the steps to be taken, and assi...

21 CFR 117.180(d) - (d) All applicable training in the development and application of risk-based preventive controls ...

21 CFR 117.130(a)(1) - (1) You must conduct a hazard analysis to identify and evaluate, based on experience, illness dat...

21 CFR 117.130(a)(2) - (2) The hazard analysis must be written regardless of its outcome.

21 CFR 117.126(a)(1) - (1) You must prepare, or have prepared, and implement a written food safety plan.

21 CFR 117.126(a)(2) - (2) The food safety plan must be prepared, or its preparation overseen, by one or more preventive...

21 CFR 117.150(d) - (d) Records. All corrective actions (and, when appropriate, corrections) taken in accordance wit...

21 CFR 117.150(a)(1) - (1) You must establish and implement written corrective action procedures that must be taken if p...

21 CFR 117.150(a)(2) - (2) The corrective action procedures must describe the steps to be taken to ensure that:

21 CFR 117.150(b)(2) - (2) If any of the circumstances listed in paragraph (b)(1) of this section apply, you must:

21 CFR 117.155(b) - (b) Documentation. All verification activities conducted in accordance with this section must be...

21 CFR 117.135(b) - (b) Preventive controls must be written.

21 CFR 117.135(c)(1) - (1) Process controls. Process controls include procedures, practices, and processes to ensure th...

21 CFR 117.135(c)(2) - (2) Food allergen controls. Food allergen controls include procedures, practices, and processes ...

21 CFR 117.135(c)(3) - (3) Sanitation controls. Sanitation controls include procedures, practices, and processes to ens...

21 CFR 117.135(c)(6) - (6) Other controls. Preventive controls include any other procedures, practices, and processes n...

21 CFR 117.135(a)(1) - (1) You must identify and implement preventive controls to provide assurances that any hazards re...

21 CFR 117.190(a) - (a) You must establish and maintain the following records documenting implementation of the food ...

21 CFR 117.201(a) - (a) Attestations to be submitted

21 CFR 117.201(a)(2)(i) - (i) An attestation that you have identified the potential hazards associated with the food being ...

21 CFR 117.206(a) - (a) If a facility that is solely engaged in the storage of unexposed packaged food stores any suc...

21 CFR 117.206(a)(5) - (5) Establish and maintain the following records:

21 CFR 117.315 - Requirements for record retention.

21 CFR 117.320 - Requirements for official review.

21 CFR 117.305 - General requirements applying to records.

21 CFR 117.310 - Additional requirements applying to the food safety plan.

21 CFR 117.475(c) - (c) The receiving facility must document the following in records as applicable to its supply-cha...

21 CFR 117.415(a)(1) - (1) The receiving facility must approve suppliers.

21 CFR 117.415(a)(2) - (2) Except as provided by paragraphs (a)(3) and (4) of this section, the receiving facility must ...

21 CFR 117.405(c) - (c) When a supply-chain-applied control is applied by an entity other than the receiving facility...

21 CFR 117.405(a)(1) - (1) Except as provided by paragraphs (a)(2) and (3) of this section, the receiving facility must ...

21 CFR 117.420(b) - (b) Written procedures for receiving raw materials and other ingredients.

21 CFR 117.410(c) - (c) The supply-chain program must provide assurance that a hazard requiring a supply-chain-applie...

21 CFR 117.435(b) - (b) If the raw material or other ingredient at the supplier is subject to one or more FDA food sa...

21 CFR 118.4(e) - (e) Refrigeration. You must hold and transport eggs at or below 45 °F ambient temperature beginn...

21 CFR 118.4(d) (1) - Our records indicate this regulation is no longer in the CFR. See ecfr.gov for more information

21 CFR 118.4(d) (3) - Our records indicate this regulation is no longer in the CFR. See ecfr.gov for more information

21 CFR 118.4 - Salmonella Enteritidis (SE) prevention measures.

21 CFR 118.4(d) - (d) Cleaning and disinfection. You must clean and disinfect the poultry house according to these...

21 CFR 118.4(b) - (b) Biosecurity

21 CFR 118.4(b)(1) - (1) Limit visitors on the farm and in the poultry houses;

21 CFR 118.4(b)(2) - (2) Maintain practices that will protect against cross contamination when equipment is moved amon...

21 CFR 118.4(b)(3) - (3) Maintain practices that will protect against cross contamination when persons move between po...

21 CFR 118.4(b)(4) - (4) Prevent stray poultry, wild birds, cats, and other animals from entering poultry houses; and

21 CFR 118.4(b)(5) - (5) Not allow employees to keep birds at home.

21 CFR 118.4(c)(1) - (1) Monitor for rodents by visual inspection and mechanical traps or glueboards or another approp...

21 CFR 118.4(c)(2) - (2) Monitor for flies by spot cards, Scudder grills, or sticky traps or another appropriate monit...

21 CFR 118.4(c)(3) - (3) Remove debris within a poultry house and vegetation and debris outside a poultry house that m...

21 CFR 118.4(a)(1) - (1) Procurement of chicks. Chicks are procured from SE-monitored breeder flocks that meet the Na...

21 CFR 118.4(a)(2)(i) - (i) The pullet environment is tested for SE when pullets are 14 to 16 weeks of age;

21 CFR 118.6(d) - (d) If any of the four egg tests is positive for SE, you must divert, upon receiving notification...

21 CFR 118.6(c) - (c) You must conduct four egg tests, using sampling and methodology in §§ 118.7 and 118.8, on the...

21 CFR 118.6(f) - (f) If you are diverting eggs, the pallet, case, or other shipping container must be labeled and ...

21 CFR 118.6(a)(2) - (2) If you have an SE-positive environmental test at any time during the life of a flock, you mus...

21 CFR 118.8(a) - (a) Testing of environmental samples for SE. Testing to detect SE in environmental samples must ...

21 CFR 118.12(b) - (b) Inspection. Persons engaged in production of shell eggs must permit authorized representativ...

21 CFR 118.7(a) - (a) Environmental sampling. An environmental test must be done for each poultry house in accorda...

21 CFR 118.11(f) - (f) Registered egg producers must submit an update to a registration within 60-calendar days of a...

21 CFR 118.11(a) - (a) Shell egg producers covered under § 118.1(a) are required to register their farms with FDA wi...

21 CFR 118.11(e)(2) - (2) The average or usual number of layers of each house and number of poultry houses on the farm.

21 CFR 118.11(b)(2)(vi) - (vi) If any information you previously submitted was incorrect at the time of submission, you mus...

21 CFR 118.5(b) - (b) Environmental testing after an induced molting period

21 CFR 118.5(b)(1) - (1) If an environmental test at 4 to 6 weeks after the end of the molting process is negative and...

21 CFR 118.5(a) - (a) Environmental testing when laying hens are 40 to 45 weeks of age

21 CFR 118.5(a)(1) - (1) If an environmental test at 40 to 45 weeks is negative and your laying hens do not undergo in...

21 CFR 118.5(a)(2)(i) - (i) Review and make any necessary adjustments to your SE prevention plan to ensure that all measu...

21 CFR 118.9 - Administration of the Salmonella Enteritidis (SE) prevention plan.

21 CFR 118.10(e) - (e) Official review of records. You must have all records required by this part available for of...

21 CFR 118.10(d) - (d) Offsite storage of records. You may store the records required by this part, except for the ...

21 CFR 118.10(c) - (c) Length of time records must be retained. You must retain all records required by this part a...

21 CFR 118.10(b)(1) - (1) Your name and the location of your farm,

21 CFR 118.10(b)(2) - (2) The date and time of the activity that the record reflects,

21 CFR 118.10(b)(3) - (3) The signature or initials of the person performing the operation or creating the record. The ...

21 CFR 118.10(b)(4) - (4) Data and information reflecting compliance activities must be entered on records at the time ...

21 CFR 118.10(a)(1) - (1) A written SE prevention plan required by § 118.4;

21 CFR 118.10(a)(2) - (2) Documentation that pullets were “SE monitored” or were raised under “SE monitored” conditions...

21 CFR 118.10(a)(4) - (4) Records of review and of modifications of the SE prevention plan and corrective actions taken...

21 CFR 118.10(a)(3)(i) - (i) Biosecurity measures;

21 CFR 118.10(a)(3)(ii) - (ii) Rodent and other pest control measures;

21 CFR 118.10(a)(3)(iii) - (iii) Cleaning and disinfection procedures performed at depopulation, when applicable;

21 CFR 118.10(a)(3)(iv) - (iv) Refrigeration requirements;

21 CFR 118.10(a)(3)(v) - (v) Environmental and egg sampling procedures, when applicable, performed under § 118.7;

21 CFR 118.10(a)(3)(vi) - (vi) Results of SE testing, when applicable, performed under § 118.8 as required in §§ 118.4(a)(2...

21 CFR 118.10(a)(3)(vii) - (vii) Diversion of eggs, if applicable, as required in § 118.6; and

21 CFR 120.10(b) - (b) When a deviation from a critical limit occurs, and the processor does not have a corrective a...

21 CFR 120.10(c) - (c) All corrective actions taken in accordance with this section shall be fully documented in rec...

21 CFR 120.10(a) - (a) Processors may develop written corrective action plans, which become part of their HACCP plan...

21 CFR 120.14(c) - (c) Records. The importer shall maintain records, in English, that document the performance and ...

21 CFR 120.14(a) - (a) Importer requirements

21 CFR 120.14(a)(2) - (2) Have and implement written procedures for ensuring that the juice that such importer receives...

21 CFR 120.14(a)(2)(ii) - (ii) Affirmative steps to ensure that the products being offered for entry were processed under c...

21 CFR 120.11(b) - (b) Validation of the HACCP plan. Each processor shall validate that the HACCP plan is adequate ...

21 CFR 120.11(a)(2) - (2) Records that document the calibration of process monitoring instruments, in accordance with p...

21 CFR 120.11(a)(1) - (1) Verification activities shall include:

21 CFR 120.11(a)(1)(iv) - (iv) A review, including signing and dating, by an individual who has been trained in accordance ...

21 CFR 120.11(a)(1)(iv)(A) - (A) The monitoring of critical control points. The purpose of this review shall be, at a minimum,...

21 CFR 120.11(a)(1)(iv)(B) - (B) The taking of corrective actions. The purpose of this review shall be, at a minimum, to ensur...

21 CFR 120.11(a)(1)(iv)(C) - (C) The calibrating of any process monitoring instruments used at critical control points and the...

21 CFR 120.6(b) - (b) Monitoring. The processor shall monitor the conditions and practices during processing with ...

21 CFR 120.6(c) - (c) Records. Each processor shall maintain SSOP records that, at a minimum, document the monitor...

21 CFR 120.6(a) - (a) Sanitation controls. Each processor shall have and implement a sanitation standard operating...

21 CFR 120.12(e) - (e) Official review. All records required by this part shall be available for review and copying...

21 CFR 120.12(a) - (a) Required records. Each processor shall maintain the following records documenting the proces...

21 CFR 120.12(g) - (g) Records maintained on computers. The maintenance of computerized records, in accordance with...

21 CFR 120.12(c) - (c) Documentation.

21 CFR 120.12(b) - (b) General requirements

21 CFR 120.12(b)(4) - (4) Where appropriate, the identity of the product and the production code, if any. Processing an...

21 CFR 120.12(d)(1) - (1) All records required by this part shall be retained at the processing facility or at the impo...

21 CFR 120.12(d)(2) - (2) Offsite storage of processing records required by paragraphs (a)(1) and (a)(4) of this sectio...

21 CFR 120.12(d)(3) - (3) If the processing facility is closed for a prolonged period between seasonal packs, the recor...

21 CFR 120.8(a) - (a) HACCP plan. Each processor shall have and implement a written HACCP plan whenever a hazard a...

21 CFR 120.8(b)(1) - (1) List all food hazards that are reasonably likely to occur as identified in accordance with § ...

21 CFR 120.8(b)(2) - (2) List the critical control points for each of the identified food hazards that is reasonably l...

21 CFR 120.8(b)(3) - (3) List the critical limits that shall be met at each of the critical control points;

21 CFR 120.8(b)(4) - (4) List the procedures, and the frequency with which they are to be performed, that will be used...

21 CFR 120.8(b)(5) - (5) Include any corrective action plans that have been developed in accordance with § 120.10(a), ...

21 CFR 120.8(b)(6) - (6) List the validation and verification procedures, and the frequency with which they are to be ...

21 CFR 120.8(b)(7) - (7) Provide for a recordkeeping system that documents the monitoring of the critical control poin...

21 CFR 120.7(c) - (c) In evaluating what food hazards are reasonably likely to occur, consideration should be given...

21 CFR 120.7(d) - (d) Processors should evaluate product ingredients, processing procedures, packaging, storage, an...

21 CFR 120.7(a) - (a) Each processor shall develop, or have developed for it, a written hazard analysis to determin...

21 CFR 120.24(b) - (b) All juice processors shall meet the requirements of paragraph (a) of this section through tre...

21 CFR 120.24(a) - (a) In order to meet the requirements of subpart A of this part, processors of juice products sha...

21 CFR 120.24(c) - (c) All juice processors shall meet the requirements of paragraphs (a) and (b) of this section an...

21 CFR 120.25(b) - (b) If the facility is producing more than one type of juice covered by this section, processors ...

21 CFR 120.25(a) - (a) One 20 milliliter (mL) sample (consisting of two 10 mL subsamples) for each 1,000 gallons of ...

21 CFR 120.25(c) - (c) Processors shall analyze each subsample for the presence of E. coli by the method entitled “A...

21 CFR 120.25 - Process verification for certain processors.

21 CFR 121.126(a) - (a) Requirement for a food defense plan. You must prepare, or have prepared, and implement a wri...

21 CFR 123.6(d) - (d) Signing and dating the HACCP plan.

21 CFR 123.6(a) - (a) Hazard analysis. Every processor shall conduct, or have conducted for it, a hazard analysis ...

21 CFR 123.6(b) - (b) The HACCP plan. Every processor shall have and implement a written HACCP plan whenever a haz...

21 CFR 123.6(c)(1) - (1) List the food safety hazards that are reasonably likely to occur, as identified in accordance...

21 CFR 123.6(c)(2) - (2) List the critical control points for each of the identified food safety hazards, including as...

21 CFR 123.6(c)(3) - (3) List the critical limits that must be met at each of the critical control points;

21 CFR 123.6(c)(4) - (4) List the procedures, and frequency thereof, that will be used to monitor each of the critical...

21 CFR 123.6(c)(5) - (5) Include any corrective action plans that have been developed in accordance with § 123.7(b), t...

21 CFR 123.6(c)(6) - (6) List the verification procedures, and frequency thereof, that the processor will use in accor...

21 CFR 123.6(c)(7) - (7) Provide for a recordkeeping system that documents the monitoring of the critical control poin...

21 CFR 123.9(f) - (f) Records maintained on computers. The maintenance of records on computers is acceptable, prov...

21 CFR 123.9(a) - (a) General requirements. All records required by this part shall include:

21 CFR 123.9(c) - (c) Official review. All records required by this part and all plans and procedures required by ...

21 CFR 123.9(b)(1) - (1) All records required by this part shall be retained at the processing facility or importer's ...

21 CFR 123.9(b)(2) - (2) Records that relate to the general adequacy of equipment or processes being used by a process...

21 CFR 123.9(b)(3) - (3) If the processing facility is closed for a prolonged period between seasonal packs, or if rec...

21 CFR 123.11(a) - (a) Sanitation SOP. Each processor should have and implement a written sanitation standard opera...

21 CFR 123.11(b) - (b) Sanitation monitoring. Each processor shall monitor the conditions and practices during proc...

21 CFR 123.11(c) - (c) Sanitation control records. Each processor shall maintain sanitation control records that, a...

21 CFR 123.10 - Training.

21 CFR 123.12(c) - (c) Records. The importer shall maintain records, in English, that document the performance and ...

21 CFR 123.12(d) - (d) Determination of compliance. There must be evidence that all fish and fishery products offer...

21 CFR 123.12(a)(2) - (2) Have and implement written verification procedures for ensuring that the fish and fishery pro...

21 CFR 123.7(c) - (c) When a deviation from a critical limit occurs and the processor does not have a corrective ac...

21 CFR 123.7(d) - (d) All corrective actions taken in accordance with this section shall be fully documented in rec...

21 CFR 123.7(a) - (a) Whenever a deviation from a critical limit occurs, a processor shall take corrective action e...

21 CFR 123.8(b) - (b) Corrective actions. Processors shall immediately follow the procedures in § 123.7 whenever a...

21 CFR 123.8(d) - (d) Recordkeeping. The calibration of process-monitoring instruments, and the performing of any ...

21 CFR 123.8(c) - (c) Reassessment of the hazard analysis. Whenever a processor does not have a HACCP plan because...

21 CFR 123.8(a) - (a) Overall verification

21 CFR 123.8(a)(1) - (1) Reassessment of the HACCP plan. A reassessment of the adequacy of the HACCP plan whenever an...

21 CFR 123.8(a)(2) - (2) Ongoing verification activities

21 CFR 123.8(a)(2)(ii) - (ii) The calibration of process-monitoring instruments; and,

21 CFR 123.8(a)(3) - (3) Records review

21 CFR 123.8(a)(3)(i) - (i) The monitoring of critical control points. The purpose of this review shall be, at a minimum,...

21 CFR 123.8(a)(3)(ii) - (ii) The taking of corrective actions. The purpose of this review shall be, at a minimum, to ensu...

21 CFR 123.8(a)(3)(iii) - (iii) The calibrating of any process control instruments used at critical control points and the ...

21 CFR 123.16 - Process controls.

21 CFR 123.28(c) - (c) To meet the requirements of paragraph (b) of this section, processors who receive shellstock ...

21 CFR 123.28(d) - (d) To meet the requirements of paragraph (b) of this section, processors who receive shucked mol...

21 CFR 123.28(a) - (a) In order to meet the requirements of subpart A of this part as they apply to microbiological ...

21 CFR 129.37(c) - (c) Single-service containers and caps or seals shall be purchased and stored in sanitary closure...

21 CFR 129.37(b) - (b) After cleaning, all multiservice containers, utensils, and disassembled piping and equipment ...

21 CFR 129.37(d) - (d) Filling, capping, closing, sealing, and packaging of containers shall be done in a sanitary m...

21 CFR 129.37(a) - (a) The product water-contact surfaces of all multiservice containers, utensils, pipes, and equip...

21 CFR 129.35(b) - (b) Air under pressure. Whenever air under pressure is directed at product water or a product wa...

21 CFR 129.35(c) - (c) Locker and lunchrooms. When employee locker and lunchrooms are provided, they shall be separ...

21 CFR 129.35(a)(1) - (1) Product water. The product water supply for each plant shall be from an approved source prop...

21 CFR 129.35(a)(2) - (2) Operations water. If different from the product water supply, the operations water supply sh...

21 CFR 129.35(a)(3)(i) - (i) Samples of source water from each source in use by the plant are to be taken and analyzed by ...

21 CFR 129.35(a)(3)(ii) - (ii) Test and sample methods shall be those recognized and approved by the government agency or a...

21 CFR 129.35(a)(3)(iii) - (iii) Analysis of the sample may be performed for the plant by competent commercial laboratories ...

21 CFR 129.35(a)(4)(i) - (i) Firms that use a public water system for source water may substitute public water system test...

21 CFR 129.35(a)(4)(iii) - (iii) Firms that do not use a public water system as the source of their water and whose source w...

21 CFR 129.35(a)(4)(iv) - (iv) The finished bottled water must comply with bottled water quality standards (§ 165.110(b) of...

21 CFR 129.20(d) - (d) The washing and sanitizing of containers for bottled drinking water shall be performed in an ...

21 CFR 129.20(c) - (c) Adequate ventilation shall be provided to minimize condensation in processing rooms, bottling...

21 CFR 129.20(b) - (b) If processing operations are conducted in other than a sealed system under pressure, adequate...

21 CFR 129.20(a) - (a) The bottling room shall be separated from other plant operations or storage areas by tight wa...

21 CFR 129.40(a)(1) - (1) All plant equipment and utensils shall be suitable for their intended use. This includes all ...

21 CFR 129.40(a)(2) - (2) All product water contact surfaces shall be constructed of nontoxic and nonabsorbant material...

21 CFR 129.80(d) - (d) Sanitizing operations. Sanitizing operations, including those performed by chemical means or...

21 CFR 129.80(h) - (h) Record retention. All records required by §§ 129.1, 129.20, 129.35, 129.37, 129.40, and 129....

21 CFR 129.80(a) - (a) Treatment of product water. All treatment of product water by distillation, ion-exchanging, ...

21 CFR 129.80(c) - (c) Cleaning and sanitizing solutions. Cleaning and sanitizing solutions utilized by the plant s...

21 CFR 129.80(e) - (e) Unit package production code. Each unit package from a batch or segment of a continuous prod...

21 CFR 129.80(f) - (f) Filling, capping, or sealing. During the process of filling, capping or sealing either singl...

21 CFR 129.80(b)(1) - (1) Multiservice primary containers shall be adequately cleaned, sanitized, and inspected just pr...

21 CFR 129.80(g)(1) - (1) For bacteriological purposes, take and analyze at least once a week for total coliform a repr...

21 CFR 129.80(g)(2) - (2) For chemical, physical, and radiological purposes, take and analyze at least annually a repre...

21 CFR 129.80(g)(3) - (3) Analyze such samples by methods approved by the government agency or agencies having jurisdic...

21 CFR 70.20 - Packaging requirements for straight colors (other than hair dyes).

21 CFR 70.25 - Labeling requirements for color additives (other than hair dyes).

21 CFR 700.25(c) - (c) Labeling. Each retail package of a cosmetic product covered by this section, except aerosol ...

21 CFR 74.705(e) - (e) Certification. All batches of FD&C Yellow No. 5 shall be certified in accordance with regula...

21 CFR 74.101(e) - (e) Certification. All batches of FD&C Blue No. 1 shall be certified in accordance with regulati...

21 CFR 80.38(a) - (a) Immediately upon notification that a batch of color additive has been certified, the person r...

21 CFR 80.37 - Treatment of batch pending certification.

Citations within the context of their regulations

Part 1: General Enforcement Regulations

Subpart H: Registration of Food Facilities

21 CFR 1.234 - How and when do you update your facility's registration information?

21 CFR 1.225 - Who must register under this subpart?

Subpart L: Foreign Supplier Verification Programs for Food Importers

21 CFR 1.510 - How must I maintain records of my FSVP?

21 CFR 1.510(a) - (a) General requirements for records.

21 CFR 1.510(a)(1) - (1) You must keep records as original records, true copies (such as photocopies, pictures, scanne...

21 CFR 1.510(a)(2) - (2) You must sign and date records concerning your FSVP upon initial completion and upon any modi...

21 CFR 1.510(b) - (b) Record availability.

21 CFR 1.510(b)(1) - (1) You must make all records required under this subpart available promptly to an authorized FDA...

21 CFR 1.510(b)(3) - (3) If requested in writing by FDA, you must send records to the Agency electronically, or throug...

21 CFR 1.510(c) - (c) Record retention.

21 CFR 1.510(c)(1) - (1) Except as specified in paragraph (c)(2) of this section, you must retain records referenced i...

21 CFR 1.506 - What foreign supplier verification and related activities must I conduct?

21 CFR 1.506(b) - (b) Foreign supplier verification procedures. You must establish and follow adequate written pro...

21 CFR 1.506(c) - (c) Requirement of supplier verification. The foreign supplier verification activities must prov...

21 CFR 1.506(d) - (d) Determination of appropriate foreign supplier verification activities —

21 CFR 1.506(d)(2) - (2) Verification activities for certain serious hazards. When a hazard in a food will be control...

21 CFR 1.506(d)(3) - (3) Reliance on a determination by another entity. You may rely on a determination of appropriat...

21 CFR 1.506(d)(1) - (1)

21 CFR 1.506(d)(1)(i) - (i) General. Except as provided in paragraphs (d)(2) and (3) of this section, before importing a...

21 CFR 1.506(d)(1)(ii) - (ii) Appropriate verification activities. The following are appropriate supplier verification ac...

21 CFR 1.506(e) - (e) Performance of foreign supplier verification activities —

21 CFR 1.506(e)(3) - (3) Review of results of verification activities. You must promptly review and assess the result...

21 CFR 1.506(e)(1) - (1) Verification activities

21 CFR 1.506(e)(1) - (1) Verification activities

21 CFR 1.506(e)(1)(ii) - (ii) Sampling and testing of the food. You must retain documentation of each sampling and testin...

21 CFR 1.506(e)(1)(iii) - (iii) Review of the foreign supplier's relevant food safety records. You must retain documentati...

21 CFR 1.506(e)(1)(i) - (i) Onsite audit of the foreign supplier.

21 CFR 1.506(e)(1)(i)(B) - (B) If the food is subject to one or more FDA food safety regulations, an onsite audit of the for...

21 CFR 1.506(e)(1)(i)(D) - (D) You must retain documentation of each onsite audit, including the audit procedures, the dates...

21 CFR 1.506(e)(1)(i)(E) - (E) The following inspection results may be substituted for an onsite audit, provided that the in...

21 CFR 1.506(e)(1)(iv) - (iv) Other appropriate activity.

21 CFR 1.506(e)(1)(iv)(B) - (B) You must retain documentation of each activity conducted in accordance with paragraph (e)(1)(...

21 CFR 1.506(e)(2) - (2) Reliance upon performance of activities by other entities.

21 CFR 1.506(e)(2)(ii) - (ii) You may not rely on the foreign supplier itself or employees of the foreign supplier to perf...

21 CFR 1.506(a) - (a) Use of approved foreign suppliers.

21 CFR 1.506(a)(1) - (1) You must establish and follow written procedures to ensure that you import foods only from fo...

21 CFR 1.506(a)(2) - (2) You may rely on an entity other than your foreign supplier to establish the procedures and pe...

21 CFR 1.508 - What corrective actions must I take under my FSVP?

21 CFR 1.508(a) - (a) You must promptly take appropriate corrective actions if you determine that a foreign supplie...

21 CFR 1.508(b) - (b) If you determine, by means other than the verification activities conducted under § 1.506 or ...

21 CFR 1.507 - What requirements apply when I import a food that cannot be consumed without the hazards being co...

21 CFR 1.507(a) - (a) Circumstances

21 CFR 1.507(a) - (a) Circumstances

21 CFR 1.507(a)(1) - (1) You determine and document that the type of food (e.g., raw agricultural commodities such as ...

21 CFR 1.507(a)(2) - (2) You rely on your customer who is subject to the requirements for hazard analysis and risk-bas...

21 CFR 1.507(a)(2)(i) - (i) Disclose in documents accompanying the food, in accordance with the practice of the trade, th...

21 CFR 1.507(a)(2)(ii) - (ii) Annually obtain from your customer written assurance, subject to the requirements of paragra...

21 CFR 1.507(a)(3) - (3) You rely on your customer who is not subject to the requirements for hazard analysis and risk...

21 CFR 1.507(a)(3)(i) - (i) Disclose in documents accompanying the food, in accordance with the practice of the trade, th...

21 CFR 1.502 - What foreign supplier verification program (FSVP) must I have?

21 CFR 1.502(a) - (a) General. Except as specified in paragraph (b) of this section, for each food you import, you...

21 CFR 1.502(b) - (b) Low-acid canned foods —

21 CFR 1.502(b)(1) - (1) Importers of low-acid canned foods not subject to further manufacturing or processing. With ...

21 CFR 1.512 - What FSVP may I have if I am a very small importer or I am importing certain food from certain sm...

21 CFR 1.512(c) - (c) Requirements for importers of food from certain small foreign suppliers. The following addit...

21 CFR 1.512(c)(1) - (1) Evaluation of foreign supplier compliance history —

21 CFR 1.512(c)(1)(i) - (i) Initial evaluation. Except as specified in paragraph (c)(1)(iii) of this section, in approvi...

21 CFR 1.512(c)(1)(iii) - (iii) Review of another entity's evaluation or reevaluation of foreign supplier compliance histor...

21 CFR 1.512(c)(3) - (3) Use of approved foreign suppliers.

21 CFR 1.512(c)(3)(i) - (i) You must establish and follow written procedures to ensure that you import foods only from fo...

21 CFR 1.512(b) - (b) Applicable requirements —

21 CFR 1.512(b)(2) - (2) Additional requirements. If this section applies and you choose to comply with the requireme...

21 CFR 1.512(b)(4) - (4) Corrective actions. You must promptly take appropriate corrective actions if you determine t...

21 CFR 1.512(b)(1) - (1) Documentation of eligibility —

21 CFR 1.512(b)(1)(ii) - (ii) Small foreign supplier status. If you are a importing food from a small foreign supplier as...

21 CFR 1.512(b)(1)(i) - (i) Very small importer status.

21 CFR 1.512(b)(1)(i)(A) - (A) If you are a very small importer and you choose to comply with the requirements in this secti...

21 CFR 1.512(b)(3) - (3) Foreign supplier verification activities.

21 CFR 1.512(b)(3)(i) - (i) If you are a very small importer, for each food you import, you must obtain written assurance...

21 CFR 1.512(b)(3)(ii) - (ii) If your foreign supplier is a qualified facility as defined by § 117

21 CFR 1.512(b)(3)(ii) - (ii) If your foreign supplier is a qualified facility as defined by § 117

21 CFR 1.512(b)(3)(ii)(A) - (A) A brief description of the preventive controls that the supplier is implementing to control t...

21 CFR 1.512(b)(5) - (5) Records —

21 CFR 1.512(b)(5)(i) - (i) General requirements for records.

21 CFR 1.512(b)(5)(i)(B) - (B) You must sign and date records concerning your FSVP upon initial completion and upon any modi...

21 CFR 1.512(b)(5)(ii) - (ii) Availability.