FDA WARNING_LETTER - Oak Hill Farm - November 06, 2014

On November 4 and 6, 2014, the FDA inspected Oak Hill Farm, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved the sale of an adulterated bob veal calf for slaughter, which contained neomycin residues at (b)(4) ppm in the kidney, exceeding the established tolerance for cattle and having no acceptable level for veal calves, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). The investigation also revealed that the farm held animals under insanitary conditions, including a failure to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4). Furthermore, the new animal drug (b)(4) (neomycin sulfate) was adulterated due to extralabel use, as it was not administered according to its approved labeling, lacked licensed veterinarian supervision (violating 21 C.F.R. 530.11(a)), and resulted in illegal residues (violating 21 C.F.R. 530.11(c)). This extralabel use caused the drug to be unsafe and adulterated under 21 U.S.C. § 360b(a) and 21 U.S.C. § 351(a)(5). Oak Hill Farm is required to take prompt corrective action, establish preventative procedures, and notify the FDA in writing within 15 working days, providing documentation of corrections to avoid further regulatory action like seizure or injunction.