FDA WARNING_LETTER - John and Maria Nunes Dairy - January 14, 2008

An FDA inspection of Nunes' dairy operation on January 7, 11, and 14, 2008, revealed multiple violations. A dairy cow consigned for slaughter on August 14, 2007, was found to have gentamicin residues in its kidney, rendering it adulterated under 21 U.S.C. § 342(a)(2)(C)(ii) as no tolerance for gentamicin in cattle edible tissues exists (21 C.F.R. 556.300).

The operation lacked an adequate system to prevent medicated animals with harmful drug residues from entering the food supply, specifically failing to maintain complete treatment records, violating 21 U.S.C. § 342(a)(4). Furthermore, Nunes provided a false guaranty on August 14, 2007, certifying no illegal drug residues, a prohibited act under 21 U.S.C. § 331(h).

New animal drugs, including Gentamicin Sulfate Solution, Oxytetracycline Hydrochloride Injection, Sulfadimethoxine Injection 40%, Sulfadimethoxine Boluses, and Penicillin G Procaine, were adulterated (21 U.S.C. § 351(a)(5)) due to extralabel use not conforming to approved labeling or 21 C.F.R. Part 530