FDA WARNING_LETTER - Berlin Valley Farm - August 28, 2013

The FDA issued a Warning Letter to Mr. Miller following an investigation of his dairy operation in Millersburg, Ohio, on August 15 and 28, 2013. The letter details multiple violations of the Federal Food, Drug, and Cosmetic Act. A bob veal calf sold for slaughter on May 21, 2013, was found to have 22.3 ppm of neomycin residue in its kidney, exceeding the 7.2 ppm tolerance (21 CFR 556.430) and rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii). The investigation also revealed that animals were held under insanitary conditions, increasing the likelihood of medicated animals with harmful residues entering the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4). Specific deficiencies included a failure to maintain complete treatment records and a lack of a drug inventory system. Furthermore, the firm adulterated new animal drugs by using NT Concentrate (containing neomycin sulfate and oxytetracycline) extralabel. This involved administering the medicated feed to an animal class not specified on its approved labeling (veal calf), violating 21 CFR 530.11(a), and resulting in an illegal residue, violating 21 CFR 530.11(c). These actions caused the medicated feed to be unsafe and adulterated under 21 U.S.C. § 360b(a), 21 U.S.C. § 351(a)(5), and 21 U.S.C. § 351(a)(6), as extralabel use of medicated feed is prohibited by 21 CFR 530.11(b). Mr. Miller is required to take prompt corrective action and establish preventative procedures, responding to the FDA within fifteen working days. Failure to comply may lead to regulatory actions such as seizure or injunction.