Warning Letters

Review Warning Letters by infraction

Regulations

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

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

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

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

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)(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 225.102(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 225.115(b)(1) - (1) The original or copy of a record of each oral and written complaint received relating to the ...

21 CFR 225.120 - Buildings and grounds.

21 CFR 225.165 - Equipment cleanout procedures.

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

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

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

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

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)(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 507.19(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 507.27(a) - (a) Animal food held for distribution must be held under conditions that will protect against con...

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

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

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

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

21 CFR 507.31(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 507.40(c)(1) - (1) You must document the monitoring of preventive controls in accordance with this section in re...

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

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

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

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

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

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

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