Warning Letters

Review Warning Letters by infraction

Regulations

21 CFR 1.225 - Who must register under this subpart?

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 - What evaluation for foreign supplier approval and verification must I conduct?

21 CFR 1.505(a) - (a) Evaluation of a foreign supplier's performance and the risk posed by a food.

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

21 CFR 1.505(c) - (c) Reevaluation of a foreign supplier's performance and the risk posed by a food.

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

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

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

21 CFR 1.504(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 - What hazard analysis must I conduct?

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

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

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

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 1.502(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 - 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(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) - (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)(i) - (i) If you are a very small importer, for each food you import, you must obtain written assurance...

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

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

21 CFR 1.506 - What foreign supplier verification and related activities must I conduct?

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

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

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) - (3) Process adherence and information —

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

21 CFR 108.35 - Thermal processing of low-acid foods packaged in hermetically sealed containers.

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

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

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

21 CFR 110.10(b) - (b) Cleanliness. All persons working in direct contact with food, food-contact surfaces, and foo...

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

21 CFR 110.35 - Sanitary operations.

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

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

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 110.37(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 - Sanitary facilities and controls.

21 CFR 110.37(b) - (b) Plumbing. Plumbing shall be of adequate size and design and adequately installed and maintai...

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(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)(5) - (5) Readily understandable signs directing employees handling unprotected food, unprotected food-...

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

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

21 CFR 110.20 - Plant and grounds.

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

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

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

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

21 CFR 110.93 - Warehousing and distribution.

21 CFR 110.80 - Processes and controls.

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

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

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 111.14(b) - (b) You must make and keep the following records:

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

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

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

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

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

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

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

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

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

21 CFR 111.15 - What sanitation requirements apply to your physical plant and grounds?

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

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

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

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

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

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

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 - Under this subpart D, what records must you make and keep?

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

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

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

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

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 - What must you do to determine whether specifications are met?

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

21 CFR 111.75(a) - (a) Before you use a component, you must:

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) - (ii) Rely on a certificate of analysis from the supplier of the component that you receive, provi...

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

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(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 111.95 - Under this subpart E, what records must you make and keep?

21 CFR 111.95(b) - (b) Under this subpart E, you must make and keep the following records:

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

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

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

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 - What are the requirements for reserve samples?

21 CFR 111.83(b) - (b) The reserve samples must:

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

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

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 - What specifications must you establish?

21 CFR 111.70(c) - (c) For the in-process production:

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 111.65 - What are the requirements for quality control operations?

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

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

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

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

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

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

21 CFR 111.105 - What must quality control personnel do?

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

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

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

21 CFR 111.140 - Under this subpart F, what records must you make and keep?

21 CFR 111.140(b) - (b) You must make and keep the following records:

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) - (2) Written documentation, at the time of performance, that quality control personnel performed t...

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 111.113(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) - (a) Quality control personnel must conduct a material review and make a disposition decision if:

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)(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 111.130 - What quality control operations are required for returned dietary supplements?

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

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

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

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

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(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)(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 111.123(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 111.135 - What quality control operations are required for product complaints?

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

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 111.155(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 111.170 - What requirements apply to rejected components, packaging, and labels, and to rejected products t...

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 - What requirements apply to packaging and labels received?

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

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

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

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 - What requirements apply to a product received for packaging or labeling as a dietary supplement (...

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

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

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

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

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

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

21 CFR 111.210 - What must the master manufacturing record include?

21 CFR 111.210(h) - (h) Written instructions, including the following:

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 - What is the requirement to establish a master manufacturing record?

21 CFR 111.205(b) - (b) The master manufacturing record must:

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

21 CFR 111.255 - What is the requirement to establish a batch production record?

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

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

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

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

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

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

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

21 CFR 111.260 - What must the batch record include?

21 CFR 111.260(l) - (l) Documentation at the time of performance that quality control personnel:

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(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 111.260(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(a) - (a) The batch, lot, or control number:

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

21 CFR 111.260(a)(2) - (2) That you assign in accordance with § 111.415(f) for the following:

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

21 CFR 111.325 - Under this subpart J, what records must you make and keep?

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

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

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

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

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

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

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

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

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

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

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

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

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 - Under this subpart L, what records must you make and keep?

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 - What requirements apply to repackaging and relabeling?

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

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

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

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

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

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

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

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) - (b) You must make and keep the following records:

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

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

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

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

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

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

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

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

21 CFR 111.535(b) - (b) You must make and keep the following records:

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 111.503 - 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 111.560(c) - (c) The review and investigation of the product complaint by a qualified person, and the review b...

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

21 CFR 111.560 - What requirements apply to the review and investigation of a product complaint?

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 - Under this subpart O, what records must you make and keep?

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)(ii) - (ii) The written record of the product complaint must include the following:

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

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

21 CFR 111.610 - What records must be made available to FDA?

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

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

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

21 CFR 112.32 - What hygienic practices must personnel use?

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

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

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

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

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

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

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

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

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

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

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

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

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 113.60(c) - (c) Coding. Each hermetically sealed container of low-acid processed food shall be marked with a...

21 CFR 113.60(d) - (d) Postprocess handling. Container handling equipment used in handling filled containers shall ...

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)(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 113.87(b) - (b) A system for product traffic control in the retort room shall be established to prevent unret...

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(a) - (a) Operating processes and retort venting procedures to be used for each product and container s...

21 CFR 113.89 - Deviations in processing, venting, or control of critical factors.

21 CFR 113.83 - Establishing scheduled processes.

21 CFR 113.100(d) - (d) Records of the accuracy of a reference device maintained by the processor shall include:

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(a) - (a) Processing and production information shall be entered at the time it is observed by the reto...

21 CFR 113.100(a)(4) - (4) Aseptic processing and packaging systems. Product temperature in the holding tube outlet as ...

21 CFR 114.83 - Establishing scheduled processes.

21 CFR 114.89 - Deviations from 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 114.100(a) - (a) Records shall be maintained of examinations of raw materials, packaging materials, and finish...

21 CFR 114.100(c) - (c) All departures from scheduled processes having a possible bearing on public health or the saf...

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 117.4 - Qualifications of individuals who manufacture, process, pack, or hold food.

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 117.95(a) - (a) Human food by-products held for distribution as animal food without additional manufacturing ...

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(e) - (e) Sanitation of non-food-contact surfaces. Non-food-contact surfaces of equipment used in the ...

21 CFR 117.35(d) - (d) Sanitation of food-contact surfaces. All food-contact surfaces, including utensils and food-...

21 CFR 117.35(a) - (a) General maintenance. Buildings, fixtures, and other physical facilities of the plant must be...

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 117.40(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 117.93 - Warehousing and distribution.

21 CFR 117.37 - Sanitary facilities and controls.

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(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)(8) - (8) Raw materials and other ingredients that are food allergens, and rework that contains food al...

21 CFR 117.130(a) - (a) Requirement for a hazard analysis.

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 117.150(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 117.126(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 117.135(b) - (b) Preventive controls must be written.

21 CFR 117.135(a)(1) - (1) You must identify and implement preventive controls to provide assurances that any hazards re...

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 117.165(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 117.139(a) - (a) You must establish a written recall plan for the food.

21 CFR 117.160(a) - (a) You must validate that the preventive controls identified and implemented in accordance with ...

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 117.305 - General requirements applying to records.

21 CFR 117.410(c) - (c) The supply-chain program must provide assurance that a hazard requiring a supply-chain-applie...

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(a)(1) - (1) Except as provided by paragraphs (a)(2) and (3) of this section, the receiving facility must ...

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 118.7(a) - (a) Environmental sampling. An environmental test must be done for each poultry house in accorda...

21 CFR 118.7 - Sampling methodology for Salmonella Enteritidis (SE).

21 CFR 118.8(a) - (a) Testing of environmental samples for SE. Testing to detect SE in environmental samples must ...

21 CFR 118.8 - Testing methodology for Salmonella Enteritidis (SE).

21 CFR 118.5(b) - (b) Environmental testing after an induced molting period

21 CFR 118.5(a) - (a) Environmental testing when laying hens are 40 to 45 weeks of age

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 118.10(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 - Recordkeeping requirements for the Salmonella Enteritidis (SE) prevention plan.

21 CFR 118.10(b) - (b) General requirements for records maintained by shell egg producers. All records required by ...

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) - (a) Records: You must maintain the following records documenting your SE prevention measures:

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 118.4(d) - (d) Cleaning and disinfection. You must clean and disinfect the poultry house according to these...

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 - Salmonella Enteritidis (SE) prevention measures.

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(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(a) - (a) Pullets. You must procure pullets that are SE monitored or raise pullets under SE monitored ...

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) - (2) Environmental testing.

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 118.9 - Administration of the Salmonella Enteritidis (SE) prevention plan.

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 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)(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 120.6(a) - (a) Sanitation controls. Each processor shall have and implement a sanitation standard operating...

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 - Sanitation standard operating procedures.

21 CFR 120.7(a) - (a) Each processor shall develop, or have developed for it, a written hazard analysis to determin...

21 CFR 120.7(c) - (c) In evaluating what food hazards are reasonably likely to occur, consideration should be given...

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 - Verification and validation.

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)(iv)(A) - (A) The monitoring of critical control points. The purpose of this review shall be, at a minimum,...

21 CFR 120.10(a) - (a) Processors may develop written corrective action plans, which become part of their HACCP plan...

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 120.12(a) - (a) Required records. Each processor shall maintain the following records documenting the proces...

21 CFR 120.12(b)(4) - (4) Where appropriate, the identity of the product and the production code, if any. Processing an...

21 CFR 120.24(a) - (a) In order to meet the requirements of subpart A of this part, processors of juice products sha...

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(c) - (c) All juice processors shall meet the requirements of paragraphs (a) and (b) of this section an...

21 CFR 123.12(d) - (d) Determination of compliance. There must be evidence that all fish and fishery products offer...

21 CFR 123.12 - Special requirements for imported products.

21 CFR 123.12(a)(2) - (2) Have and implement written verification procedures for ensuring that the fish and fishery pro...

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(a) - (a) General requirements. All records required by this part shall include:

21 CFR 123.6(d) - (d) Signing and dating the HACCP plan.

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(a) - (a) Hazard analysis. Every processor shall conduct, or have conducted for it, a hazard analysis ...

21 CFR 123.6 - Hazard analysis and Hazard Analysis Critical Control Point (HACCP) plan.

21 CFR 123.6(c) - (c) The contents of the HACCP plan. The HACCP plan shall, at a minimum:

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 123.11(c) - (c) Sanitation control records. Each processor shall maintain sanitation control records that, a...

21 CFR 123.11(b) - (b) Sanitation monitoring. Each processor shall monitor the conditions and practices during proc...

21 CFR 123.11 - Sanitation control procedures.

21 CFR 123.7(a) - (a) Whenever a deviation from a critical limit occurs, a processor shall take corrective action e...

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 - Corrective actions.

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(b) - (b) Corrective actions. Processors shall immediately follow the procedures in § 123.7 whenever a...

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)(3) - (3) Records review

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 129.80(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(f) - (f) Filling, capping, or sealing. During the process of filling, capping or sealing either singl...

21 CFR 129.80(g)(1) - (1) For bacteriological purposes, take and analyze at least once a week for total coliform a repr...