FDA WARNING_LETTER - Kuiper Dairy, LLC - November 02, 2012

The FDA conducted an inspection of Kuiper Dairy, LLC from October 30 to November 2, 2012, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of an adulterated dairy cow for slaughter, with tissue samples revealing penicillin residues at 1.16 ppm, significantly exceeding the 0.05 ppm tolerance (21 C.F.R. 556.510), thus violating FD&C Act section 402(a)(2)(C)(ii). Further, the dairy held animals under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, which constitutes adulteration under FD&C Act section 402(a)(4). The firm also adulterated the new animal drug (b)(4) (penicillin G procaine) by not using it according to its approved labeling. Specifically, extralabel use of this drug occurred without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a), and resulted in illegal drug residues, violating 21 C.F.R. 530.11(d). These actions rendered the drug unsafe and adulterated under FD&C Act sections 512(a) and 501(a)(5). FDA acknowledged the firm's November 7, 2012, response but deemed it lacking sufficient detail for evaluation, stating corrections would be verified during a subsequent inspection. Kuiper Dairy is required to take prompt corrective actions, establish preventative procedures, and provide a detailed written response within fifteen working days, outlining steps taken or planned, with supporting documentation, to avoid potential regulatory actions like seizure or injunction.