Citations within the context of their regulations

Review the enforcement history for every citation given out with the Veterinary sector.

21 CFR 225.10(b)(1) - (1) All employees involved in the manufacture of medicated feeds shall have an understanding of t...

21 CFR 225.10(b)(2) - (2) The manufacturer shall provide an on-going program of evaluation and supervision of employees...

21 CFR 225.20(a) - (a) The location, design, construction, and physical size of the buildings and other production f...

21 CFR 225.20(b)(1) - (1) The building grounds shall be adequately drained and routinely maintained so that they are re...

21 CFR 225.20(b)(2) - (2) The building(s) shall be maintained in a reasonably clean and orderly manner.

21 CFR 225.20(b)(3) - (3) The building(s) shall be of suitable construction to minimize access by rodents, birds, insec...

21 CFR 225.20(b)(4) - (4) The buildings shall provide adequate space and lighting for the proper performance of the fol...

21 CFR 225.30(a) - (a) Equipment which is designed to perform its intended function and is properly installed and us...

21 CFR 225.30(b)(1) - (1) All equipment shall possess the capability to produce a medicated feed of intended potency, s...

21 CFR 225.30(b)(2) - (2) All equipment shall be maintained in a reasonably clean and orderly manner.

21 CFR 225.30(b)(3) - (3) All equipment, including scales and liquid metering devices, shall be of suitable size, desig...

21 CFR 225.30(b)(4) - (4) All scales and metering devices shall be tested for accuracy upon installation and at least o...

21 CFR 225.30(b)(6) - (6) All equipment shall be designed, constructed, installed and maintained so as to facilitate in...

21 CFR 225.65(b) - (b) All equipment, including that used for storage, processing, mixing, conveying, and distributi...

21 CFR 225.65(b)(2) - (2) If flushing is utilized, the flush material shall be properly identified, stored, and used in...

21 CFR 225.65(b)(3) - (3) If sequential production of medicated feeds is utilized, it shall be on a predetermined basis...

21 CFR 225.58(c) - (c) The originals or copies of all results of assays, including those from State feed control off...

21 CFR 225.58(e) - (e) Corrective action shall include provisions for discontinuing distribution where the medicated...

21 CFR 225.58(d) - (d) Where the results of assays indicate that the medicated feed is not in accord with label spec...

21 CFR 225.58(b)(1) - (1) For feeds requiring a medicated feed mill license (Form FDA 3448) for their manufacture and m...

21 CFR 225.42(b) - (b) The receipt, storage, and inventory of drugs, including undiluted drug components, medicated ...

21 CFR 225.42(b)(1) - (1) Incoming shipments of drugs shall be visually examined for identity and damage. Drugs which h...

21 CFR 225.42(b)(2) - (2) Packaged drugs in the storage areas shall be stored in their original closed containers.

21 CFR 225.42(b)(3) - (3) Bulk drugs shall be identified and stored in a manner such that their identity, strength, qua...

21 CFR 225.42(b)(4) - (4) Drugs in the mixing areas shall be properly identified, stored, handled, and controlled to ma...

21 CFR 225.42(b)(5) - (5) A receipt record shall be prepared and maintained for each lot of drug received. The receipt ...

21 CFR 225.42(b)(6) - (6) A daily inventory record for each drug used shall be maintained and shall list by manufacture...

21 CFR 225.42(b)(7) - (7) Drug inventory shall be maintained of each lot or shipment of drug by means of a daily compar...

21 CFR 225.80(a) - (a) Appropriate labeling identifies the medicated feed, and provides the user with directions for...

21 CFR 225.80(b)(1) - (1) Labels and labeling, including placards, shall be received, handled, and stored in a manner t...

21 CFR 225.80(b)(2) - (2) Labels and labeling, including placards, upon receipt from the printer shall be proofread aga...

21 CFR 225.80(b)(3) - (3) In those instances where medicated feeds are distributed in bulk, complete labeling shall acc...

21 CFR 225.80(b)(4) - (4) Label stock shall be reviewed periodically and discontinued labels shall be discarded.

21 CFR 225.110(b)(1) - (1) Each distribution record shall include the date of shipment, the name and address of purchase...

21 CFR 225.102(a) - (a) The Master Record File provides the complete procedure for manufacturing a specific product, ...

21 CFR 225.102(b)(1) - (1) A Master Record File shall be prepared, checked, dated, and signed or initialed by a qualifie...

21 CFR 225.102(b)(2) - (2) The original production record or copy thereof shall be prepared by qualified personnel for e...

21 CFR 225.102(b)(4) - (4) Batch production records shall be checked by a responsible individual at the end of the worki...

21 CFR 225.102(b)(5) - (5) Each batch or production run of medicated feed shall be identified with its own individual ba...

21 CFR 225.115(b)(1) - (1) The original or copy of a record of each oral and written complaint received relating to the ...

21 CFR 225.135 - Work and storage areas.

21 CFR 225.120 - Buildings and grounds.

21 CFR 225.158 - Laboratory assays.

21 CFR 225.165 - Equipment cleanout procedures.

21 CFR 225.202 - Formula, production, and distribution records.

21 CFR 226.1 - Current good manufacturing practice.

21 CFR 226.20(b) - (b) Provide adequate lighting and ventilation, and when necessary for the intended production or ...

21 CFR 226.30(e) - (e) Be of suitable size and accuracy for use in any intended measuring, mixing, or weighing opera...

21 CFR 226.30(c) - (c) Be constructed to facilitate adjustment, cleaning, and maintenance, and to assure uniformity ...

21 CFR 226.42(a) - (a) Drug components, including undiluted drugs and any intermediate mixes containing drugs used i...

21 CFR 226.58(b) - (b) The establishment of specifications for Type A medicated article(s) and a description of nece...

21 CFR 226.58(a) - (a) The establishment of master records containing appropriate specifications and a description o...

21 CFR 226.58(d) - (d) A determination establishing that the drug components remain uniformly dispersed and stable i...

21 CFR 226.58(e) - (e) Adequate provision to check the reliability, accuracy, and precision of any laboratory test p...

21 CFR 226.40(b) - (b) All containers to be used for undiluted drugs, drug components, intermediate mixtures thereof...

21 CFR 226.40(d) - (d) Competent and responsible personnel shall check actual against theoretical yield of a batch o...

21 CFR 226.40(g) - (g) Production and control procedures shall include provision for discontinuing distribution of a...

21 CFR 226.40(e) - (e) Adequate procedures for cleaning of those parts of storage, mixing conveying and other equipm...

21 CFR 226.80(a)(4) - (4) To identify Type A medicated article(s) with lot or control numbers that permit determination...

21 CFR 226.80(b)(2) - (2) For careful checking of labeling for identity and conformity to the labeling specified in the...

21 CFR 226.110 - Distribution records.

21 CFR 507.7(a)(2)(i) - (i) An attestation that you have identified the potential hazards associated with the animal food...

21 CFR 507.4(d) - (d) Records that document training required by paragraph (b)(2) of this section must be establish...

21 CFR 507.4 - Qualifications of individuals who manufacture, process, pack, or hold animal food.

21 CFR 507.22(b) - (b) Holding, conveying, manufacturing, and processing systems, including gravimetric, pneumatic, ...

21 CFR 507.22(d) - (d) Instruments and controls used for measuring, regulating, or recording temperatures, pH, aw, o...

21 CFR 507.22(a)(1) - (1) All plant equipment and utensils, including equipment and utensils that do not come in contac...

21 CFR 507.22(a)(2) - (2) Equipment and utensils must be designed, constructed, and used appropriately to avoid the adu...

21 CFR 507.22(a)(4) - (4) Animal food-contact surfaces must be:

21 CFR 507.25(b)(1) - (1) Must be examined to ensure that they are suitable for manufacturing and processing into anima...

21 CFR 507.25(b)(2) - (2) Susceptible to contamination with mycotoxins or other natural toxins must be evaluated and us...

21 CFR 507.25(b)(3) - (3) If frozen, must be kept frozen. If thawing is required prior to use, it must be done in a man...

21 CFR 507.25(c)(1) - (1) Animal food must be maintained under conditions, e.g., appropriate temperature and relative h...

21 CFR 507.25(c)(2) - (2) Measures taken during manufacturing, processing, packing, and holding of animal food to signi...

21 CFR 507.25(c)(3) - (3) Work-in-process and rework must be handled in such a way that it is protected against contami...

21 CFR 507.25(c)(4) - (4) Steps such as cutting, drying, defatting, grinding, mixing, extruding, pelleting, and cooling...

21 CFR 507.25(c)(5) - (5) Filling, assembling, packaging, and other operations must be performed in such a way that pro...

21 CFR 507.25(a) - (a) Management of the establishment must ensure that:

21 CFR 507.25(a)(2) - (2) Animal food, including raw materials, other ingredients, or rework is accurately identified;

21 CFR 507.19(e) - (e) Effective measures must be taken to exclude pests from the manufacturing, processing, packing...

21 CFR 507.19(b) - (b) Animal food-contact and non-contact surfaces of utensils and equipment must be cleaned and ma...

21 CFR 507.19(c) - (c) Cleaning compounds and sanitizing agents must be safe and adequate under the conditions of us...

21 CFR 507.19(a) - (a) Buildings, structures, fixtures, and other physical facilities of the plant must be kept clea...

21 CFR 507.19(d)(2) - (2) Toxic materials described in paragraph (d)(1) of this section (e.g., cleaning compounds, sani...

21 CFR 507.19(d)(3) - (3) Other toxic materials (such as fertilizers and pesticides not included in paragraph (d)(1) of...

21 CFR 507.27(a) - (a) Animal food held for distribution must be held under conditions that will protect against con...

21 CFR 507.27(e) - (e) Unpackaged or bulk animal food must be held in a manner that does not result in unsafe cross ...

21 CFR 507.27(b) - (b) The labeling for the animal food ready for distribution must contain, when applicable, inform...

21 CFR 507.27(c) - (c) Shipping containers (e.g., totes, drums, and tubs) and bulk vehicles used to distribute anima...

21 CFR 507.20 - Water supply and plumbing.

21 CFR 507.17(c) - (c) The plant must protect animal food stored outdoors in bulk from contamination by any effectiv...

21 CFR 507.17(b) - (b) The plant must be suitable in size, construction, and design to facilitate cleaning, maintena...

21 CFR 507.17(a) - (a) The grounds around an animal food plant under the control of the management of the establishm...

21 CFR 507.36(a) - (a) If you are a manufacturer/processor, you are not required to implement a preventive control w...

21 CFR 507.38(b) - (b) The written recall plan must include procedures that describe the steps to perform the follow...

21 CFR 507.38(a)(1) - (1) Establish a written recall plan for the animal food; and

21 CFR 507.45(b) - (b) All verification activities conducted in accordance with this section must be documented in r...

21 CFR 507.49(b)(1) - (1) The method and frequency of calibrating process monitoring instruments and verification instr...

21 CFR 507.49(b)(2) - (2) Product testing as required by paragraph (a)(2) of this section. Procedures for product testi...

21 CFR 507.49(a)(1) - (1) Calibration of process monitoring and verification instruments (or checking them for accuracy...

21 CFR 507.49(a)(2) - (2) Product testing for a pathogen (or appropriate indicator organism) or other hazard;

21 CFR 507.49(a)(3) - (3) Environmental monitoring, for an environmental pathogen or for an appropriate indicator organ...

21 CFR 507.49(a)(4) - (4) Review of the following records within the specified timeframes, by (or under the oversight o...

21 CFR 507.49(a)(5) - (5) Other activities appropriate for verification of implementation and effectiveness.

21 CFR 507.42(d) - (d) All corrective actions (and, when appropriate, corrections) taken in accordance with this sec...

21 CFR 507.42(b)(2) - (2) If any of the circumstances listed in paragraph (b)(1) of this section apply, you must:

21 CFR 507.42(a)(1) - (1) You must establish and implement written corrective action procedures that must be taken if p...

21 CFR 507.42(a)(2) - (2) The corrective action procedures must describe the steps to be taken to ensure that:

21 CFR 507.31(a) - (a) You must prepare, or have prepared, and implement a written food safety plan.

21 CFR 507.31(b) - (b) One or more preventive controls qualified individuals must prepare, or oversee the preparatio...

21 CFR 507.34(b) - (b) Preventive controls must be written.

21 CFR 507.34(c)(1) - (1) Process controls. Process controls include procedures, practices, and processes to ensure the...

21 CFR 507.34(c)(2) - (2) Sanitation controls. Sanitation controls include procedures, practices, and processes to ensu...

21 CFR 507.34(c)(5) - (5) Other preventive controls. These include any other procedures, practices, and processes neces...

21 CFR 507.34(a)(1) - (1) You must identify and implement preventive controls to provide assurances that any hazards re...

21 CFR 507.40(c)(1) - (1) You must document the monitoring of preventive controls in accordance with this section in re...

21 CFR 507.51(a) - (a) If a facility that is solely engaged in the storage of unexposed packaged animal food stores ...

21 CFR 507.53(c)(1) - (1) To be a preventive controls qualified individual, the individual must have successfully compl...

21 CFR 507.50(d) - (d) You must revise the written food safety plan if a significant change in the activities conduc...

21 CFR 507.47(b) - (b) The validation of the preventive controls:

21 CFR 507.47(a) - (a) You must validate that the preventive controls identified and implemented in accordance with ...

21 CFR 507.135(b) - (b) If the raw material or other ingredient at the supplier is subject to one or more FDA food sa...

21 CFR 507.105(a)(1) - (1) Except as provided by paragraphs (a)(2) and (3) of this section, the receiving facility must ...

21 CFR 507.115(a)(1) - (1) The receiving facility must approve suppliers.

21 CFR 507.115(a)(2) - (2) Except as provided by paragraphs (a)(3) and (4) of this section, the receiving facility must ...

21 CFR 507.202(a) - (a) Records must:

21 CFR 507.202(b) - (b) All records must include:

21 CFR 507.200(c) - (c) All records required by this part must be made promptly available to a duly authorized repres...

21 CFR 511.1(b)(4) - (4) Prior to shipment of the new animal drug for clinical tests in animals, the sponsor of the in...

21 CFR 511.1(b)(7)(i) - (i) Are qualified by scientific training and/experience to evaluate the safety and/or effectivene...

21 CFR 511.1(b)(7)(ii) - (ii) Shall maintain complete records of the investigations, including complete records of the rec...

21 CFR 511.1(b)(7)(iii) - (iii) Shall furnish adequate and timely reports of the investigation to the sponsor.

21 CFR 511.1(b)(8)(ii) - (ii) Shall provide for current monitoring of the investigation by a person qualified by scientifi...

21 CFR 514.80(a)(1) - (1) Each applicant must establish and maintain indexed and complete files containing full records...

21 CFR 514.80(b)(1) - (1) Three-day NADA/ANADA field alert report. This report provides information pertaining to prod...

21 CFR 514.80(b)(2)(i) - (i) Initial report. This report provides information on each serious, unexpected adverse drug ev...

21 CFR 514.80(b)(4) - (4) Periodic drug experience report

21 CFR 514.80(b)(4)(iv)(B) - (B) Reports of adverse drug experiences in the literature must be noted in the periodic drug expe...

21 CFR 530.4 - Advertising and promotion.

21 CFR 530.13(a) - (a) This part applies to compounding of a product from approved animal or human drugs by a veteri...

21 CFR 530.13(b)(2) - (2) There is no approved new animal or approved new human drug that, when used as labeled or in c...

21 CFR 530.13(b)(3) - (3) The compounding is performed by a licensed pharmacist or veterinarian within the scope of a p...

21 CFR 530.13(b)(4) - (4) Adequate procedures and processes are followed that ensure the safety and effectiveness of th...

21 CFR 530.11(a) - (a) Extralabel use in an animal of an approved new animal drug or human drug by a lay person (exc...

21 CFR 530.11(b) - (b) Extralabel use of an approved new animal drug or human drug in or on an animal feed;

21 CFR 530.11(d) - (d) Extralabel use resulting in any residue above an established safe level, safe concentration o...

21 CFR 530.12(a) - (a) The name and address of the prescribing veterinarian. If the drug is dispensed by a pharmacy ...

21 CFR 530.12(b) - (b) The established name of the drug or, if formulated from more than one active ingredient, the ...

21 CFR 530.12(d) - (d) Any cautionary statements; and

21 CFR 530.12(c) - (c) Any directions for use specified by the veterinarian, including the class/species or identifi...

21 CFR 530.12(e) - (e) The veterinarian's specified withdrawal, withholding, or discard time for meat, milk, eggs, o...

21 CFR 530.20(a)(1) - (1) There is no approved new animal drug that is labeled for such use and that contains the same ...

21 CFR 530.20(a)(2)(i) - (i) Make a careful diagnosis and evaluation of the conditions for which the drug is to be used;

21 CFR 530.20(a)(2)(ii) - (ii) Establish a substantially extended withdrawal period prior to marketing of milk, meat, eggs,...

21 CFR 530.20(a)(2)(iii) - (iii) Institute procedures to assure that the identity of the treated animal or animals is carefu...

21 CFR 530.20(a)(2)(iv) - (iv) Take appropriate measures to assure that assigned timeframes for withdrawal are met and no i...

21 CFR 530.41(a) - (a) The following drugs, families of drugs, and substances are prohibited for extralabel animal a...

21 CFR 558.6(b)(1) - (1) In order for a VFD to be lawful, the veterinarian issuing the VFD must:

21 CFR 558.6(b)(2) - (2) The veterinarian must only issue a VFD that is in compliance with the conditions for use appr...

21 CFR 558.6(b)(3) - (3) The veterinarian must ensure that the following information is fully and accurately included ...

21 CFR 558.6(b)(3)(xv) - (xv) The veterinarian's electronic or written signature.

21 CFR 558.6(a)(1) - (1) Animal feed bearing or containing a VFD drug or a combination VFD drug (a VFD feed or combina...

21 CFR 558.6(a)(2) - (2) A VFD feed or combination VFD feed must not be fed to animals after the expiration date on th...

21 CFR 558.6(a)(3) - (3) Use and labeling of a VFD drug or a combination VFD drug in feed is limited to the approved, ...

21 CFR 558.6(a)(6) - (6) All labeling and advertising for VFD drugs, combination VFD drugs, and feeds containing VFD d...

21 CFR 558.6(c)(1) - (1) The distributor is permitted to fill a VFD only if the VFD contains all the information requi...

21 CFR 558.6(c)(2) - (2) The distributor is permitted to distribute an animal feed containing a VFD drug or combinatio...

21 CFR 558.6(c)(4) - (4) In addition to other applicable recordkeeping requirements found in this section, if the dist...

21 CFR 558.6(c)(5) - (5) A distributor of animal feed containing a VFD drug must notify FDA prior to the first time it...

21 CFR 558.6(c)(8) - (8) A distributor is permitted to distribute a VFD feed to another distributor only if the origin...

21 CFR 589.2000(f) - (f) Requirements for establishments and individuals that are responsible for feeding ruminant ani...

21 CFR 589.2000(d)(1) - (1) Protein blenders, feed manufacturers, and distributors that manufacture, blend, process, and ...

21 CFR 589.2000(e)(1) - (1) Renderers, protein blenders, feed manufacturers, distributors, and others that manufacture, p...

21 CFR 589.2000(c)(1)(i) - (i) Label the materials as follows: “Do not feed to cattle or other ruminants”; and

21 CFR 589.2000(c)(1)(ii) - (ii) Maintain records sufficient to track the materials throughout their receipt, processing, and...

21 CFR 589.2001(e) - (e) Inspection; records retention. Records required to be made available for inspection and copy...

21 CFR 589.2001(c)(1) - (1) No animal feed or feed ingredient shall be manufactured from, processed with, or otherwise co...

21 CFR 589.2001(c)(2)(i) - (i) Exclude from use in animal feed the entire carcass of cattle not inspected and passed for hum...

21 CFR 589.2001(c)(2)(ii) - (ii) If renderers remove brain and spinal cord from cattle not inspected and passed for human con...

21 CFR 589.2001(c)(2)(iii) - (iii) Once cattle materials prohibited in animal feed have been separated from other cattle mater...

21 CFR 589.2001(c)(2)(iv) - (iv) Label the cattle materials prohibited in animal feed and products that contain or may contai...

21 CFR 589.2001(c)(2)(v) - (v) Mark the cattle materials prohibited in animal feed and products that contain or may contain ...

21 CFR 589.2001(c)(2)(vi) - (vi) Establish and maintain records sufficient to track cattle materials prohibited in animal fee...

21 CFR 589.2001(c)(3)(i) - (i) Establish and maintain records sufficient to demonstrate that material rendered for use in an...