FDA WARNING_LETTER - Amting Dairy Farm - December 29, 2010
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On December 16 and 29, 2010, the FDA investigated Amting Dairy Farm, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow sold for slaughter on August 31, 2010, was found to have sulfamethazine in its liver tissue at 0.268 ppm, exceeding the 0.1 ppm tolerance, rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii).
The investigation also revealed insanitary conditions, specifically a failure to maintain complete treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under 21 U.S.C. 342(a)(4).
Furthermore, the farm adulterated new animal drugs, flunixin and oxytetracycline, by using them extra-label without veterinary supervision, violating 21 C.F.R. 530.11(a). Flunixin was administered without following the correct route or withdrawal period, and oxytetracycline without observing the withdrawal period. These actions caused the drugs to be unsafe and adulterated under 21 U.S.C. 360b(a) and 21 U.S.C. 351(a)(5).
The FDA reminded the owner
ID · bc8400a9-791c-4a75-9ecf-ef7332417f8d
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