FDA WARNING_LETTER - Profit & Loss Dairy - July 16, 2010

On July 14 and 16, 2010, the FDA inspected Profit and Loss Dairy, owned by Mr. Peter H. Schouten, and identified multiple violations of the Federal Food, Drug, and Cosmetic Act. The primary issues involved the sale of adulterated bob veal calves for food, containing unsafe residues of neomycin in kidney tissues (15.26 ppm and 16.36 ppm), exceeding the 7.2 ppm tolerance and not approved for veal calves, violating 21 U.S.C. 342(a)(2)(C)(ii). The firm was also found to hold animals under inadequate conditions, making it likely that medicated animals with harmful drug residues would enter the food supply, partly due to a failure to maintain complete treatment records, violating 21 U.S.C. 342(a)(4). Furthermore, the new animal drug (b)(4) Neomycin Oral Solution was adulterated through extralabel use in bob veal calves, for which it is not approved, leading to illegal drug residues and violating 21 U.S.C. 351(a)(5) and 21 C.F.R. Part 530. Lastly, the animal feed (whole milk) was adulterated by adding the neomycin solution and failing to use the medicated feed according to its approved labeling, as extralabel use of medicated feeds is prohibited, violating 21 U.S.C. 351(a)(6). The FDA requires prompt corrective action and a written response within 15 working days detailing steps taken to address these violations and prevent recurrence, noting a previous warning letter issued in 2001. Failure to comply may result in regulatory action.