FDA WARNING_LETTER - A.B. Cole Dairy Farm - December 06, 2007

An FDA investigation conducted on November 13 and December 6, 2007, at A.B. Cole Dairy Farm in Meshoppen, Pennsylvania, revealed significant violations concerning animal drug residues. The firm offered a bob veal calf for slaughter that was found to be adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Tissue samples from the slaughtered animal showed sulfamethazine residues at 46.18 ppm in muscle and 36.41 ppm in liver, significantly exceeding the established tolerance of 0.1 ppm (21 C.F.R. 556.670). The investigation also identified that the farm holds animals under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply. Specifically, the firm lacks an adequate system to ensure proper drug withdrawal times for medicated animals and failed to maintain treatment records. As a producer of food animals, A.B. Cole Dairy Farm is responsible for ensuring compliance with the law. The FDA requires prompt corrective action to address these violations and prevent recurrence. A written response detailing corrective steps, including documentation, is required within fifteen working days to the Philadelphia District office. Failure to comply may result in further regulatory action, including seizure or injunction.