FDA WARNING_LETTER - Ken Corscadden - August 12, 2010

The FDA conducted an investigation of Corscadden Family Farm in Richville, New York, across multiple dates in 2010, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The farm was found to have offered for sale animals (bob veal calves and a dairy cow) for slaughter as food that were adulterated, containing unsafe residues of Tetracycline and Penicillin above established tolerances (21 C.F.R. 556.720, 556.510), violating section 402(a)(2)(C)(ii) of the Act. Furthermore, animals were held under inadequate conditions, such as a failure to maintain complete treatment records, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, which constitutes adulteration under section 402(a)(4). The farm also adulterated new animal drugs ((b)(4) and (b)(4)) through extralabel use. Specifically, tetracycline and penicillin were administered without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a), and these extralabel uses resulted in illegal drug residues, violating 21 C.F.R. 530.11(d). These actions caused the drugs to be unsafe and adulterated under sections 512(a) and 501(a)(5) of the Act. The FDA requires prompt corrective action, including establishing procedures to prevent recurrence. A written response detailing corrective steps and timelines must be submitted within fifteen working days, with potential regulatory actions like seizure or injunction for non-compliance.