FDA WARNING_LETTER - Michael P. Ferry Inc. - June 02, 2011

An FDA inspection of Michael P. Ferry Inc.'s dairy operation in May and June 2011 revealed multiple violations of the Federal Food, Drug, and Cosmetic Act. The firm sold three bob veal calves for slaughter that contained illegal drug residues of Neomycin and Gentamicin in edible tissues, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). The investigation also found that animals were held under inadequate conditions, including a failure to maintain treatment records, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, which constitutes adulteration under 21 U.S.C. § 342(a)(4). Furthermore, the firm adulterated new animal drugs, including Neomycin, Oxytetracycline, Penicillin G procaine, and (b)(4) Injectable Solution, through extralabel use not directed by approved labeling. Specifically, extralabel use of (b)(4) (Medicated) lacked licensed veterinary supervision and resulted in illegal residues, violating 21 C.F.R. 530.11(a) and (c). Other drugs were administered contrary to approved indications, dosages, routes, or animal classes, also without veterinary supervision (21 C.F.R. 530.11(a)). The firm also adulterated medicated animal feed, (b)(4) (Medicated), by not using it according to its approved labeling, specifically regarding animal class, which is not permitted for extralabel use (21 U.S.C. § 351(a)(6), 21 U.S.C. § 360b, 21 C.F.R. 530.11(b)). Michael P. Ferry Inc. must take prompt corrective action and respond within 15 working days, detailing steps to prevent recurrence, or face potential regulatory actions like seizure or injunction.