FDA WARNING_LETTER - Sherman Dairy - November 13, 2007

An FDA inspection of a dairy operation in Winton, California, conducted in November 2007, revealed significant violations concerning animal drug residues and extralabel drug use. The firm offered an animal for slaughter as food that was adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specifically, a dairy cow consigned for slaughter had penicillin residues in its kidney at 0.29 ppm, exceeding the established tolerance of 0.05 ppm (21 C.F.R. 556.510), rendering the food adulterated. The investigation also found inadequate conditions for holding animals, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, partly due to a lack of an adequate system for ensuring proper drug withdrawal times and incomplete treatment records. Additionally, the firm adulterated the new animal drug AgriPharm PEN-AQUEOUS, Penicillin G Procaine, Injectable Suspension U.S.P., under section 501(a)(5) of the Act, by failing to use it in conformance with its approved labeling. This extralabel use included administering the drug without following the approved dosage and without the supervision of a licensed veterinarian (21 C.F.R. 530.11(a)), which resulted in illegal drug residues (21 C.F.R. 530.11(d)). The FDA requires prompt corrective action, a written response within fifteen working days detailing steps taken or planned, and documentation to prevent recurrence. Failure to comply may result in regulatory actions such as seizure and/or injunction.