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U.S. Department of Health and Human Services

Animal & Veterinary

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Regulatory Activities - July 2006

FDA Veterinarian Newsletter 2006 Volume XXI, No III

A WARNING LETTER was issued to Mark A. Hickman, president, Peco Foods, Inc, Tuscaloosa, AL, because an investigation of the licensed medicated and non-medicated animal feed mill located in Philadelphia, MS, found significant deviations from current Good Manufacturing Practice (cGMP) regulations for medicated feeds set forth in Title 21, Code of Federal Regulations, Part 225 (21 CFR 225). Such deviations cause the medicated feeds manufactured at this facility to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FFDCA). The investigation found the firm failed to conduct potency assays on at least three representative samples of each medicated feed at periodic intervals during the calendar years 2004 and 2005. In addition, the firm failed to document investigative and corrective actions when medicated feeds failed assay specifications.

A WARNING LETTER was issued to Chester J. Claudon and Russell E. Weaver, owners, Western Illinois Grain Co., Macomb, IL, because an inspection conducted at the medicated feed mill located in Fairview, IL, found that the feed mill caused the new animal drug chlortetracycline to be unsafe within the meaning of Section 512 of the FFDCA and adulterated within the meaning of Section 502(a)(5) of the FFDCA. In addition, the new animal drug chlortetracycline was misbranded within the meaning of Section 502(o) of the FFDCA. The inspection also found significant deviations from the cGMP regulations for medicated feeds. Such deviations cause the feeds being manufactured at this facility to be adulterated. The inspection revealed that the firm purchases intact bags of the new animal drug chlortetracycline, a Category I, Type A medicated article, and repackages the contents of the original bags into smaller portions, which are subsequently sold. This repacking operation establishes the firm as a producer of a new animal drug, subject to the requirements of Section 510 of the FFDCA. Establishments manufacturing Type A medicated articles are required to register annually as drug establishments and must submit a list of every drug in commercial distribution. In addition, an approved New Animal Drug Application (NADA) is required for the manufacture of a Type A medicated article containing a new animal drug unless exempted under 21 CFR 558.15. A review of the Food and Drug Administration’s (FDA) records shows that this veterinary drug repackaging establishment is not registered and has no drug listed with FDA. In addition, the firm purchased, received, and sold the new animal drug chlortetracycline in a manner that does not conform to an approved NADA in accordance with Section 512. Because the chlortetracycline is not covered by an approved NADA, the drug is unsafe, and thus is adulterated. In addition, all drugs manufactured, propagated, compounded, or processed by the firm are misbranded because the firm is not registered and/or has no drug listed. The cGMP violations included (1) failure to maintain procedures for the identification, storage, and inventory control of all Type A medicated articles and Type B medicated feeds intended for use in the manufacture of medicated feeds to aid in assuring the identity, strength, quality, and purity of these drug sources; and (2) failure to maintain buildings and grounds in a manner that minimizes vermin and pest infestation.