FDA WARNING_LETTER - Miller, David L. - February 04, 2010

An FDA inspection conducted from February 1-4, 2010, at David L. Miller's residence in Wyoming, New York, revealed significant violations of the Federal Food, Drug, and Cosmetic Act. The firm offered for sale two dairy cows for human food that were adulterated. One cow contained sulfamethazine residues (4.38 ppm in liver, 4.825 ppm in muscle), significantly exceeding the 0.1 ppm tolerance (21 CFR 556.670). The second cow had penicillin residues (0.24 ppm in liver, 0.3 ppm in kidney), surpassing the 0.05 ppm tolerance (21 CFR 556.510). Both instances render the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii).

Furthermore, the firm held animals under inadequate conditions, such as failing to maintain 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). The new animal drugs Albon Boluses and Agri-Cillin were also found to be adulterated. Their extra-label use was not under the supervision of a licensed veterinarian (21 CFR 530.11(a)) and resulted in illegal drug residues (21 CFR 530.11(d)), causing the drugs to be unsafe and adulterated under 21 U.S.C. 360b(a) and 21 U.S.C. 351(a)(5).

Mr. Miller is required to take prompt action to correct these violations and establish preventative procedures. A written response detailing corrective actions and recurrence prevention, including documentation, must be submitted within fifteen working days. Failure to comply may lead to regulatory actions like seizure or injunction.