FDA WARNING_LETTER - Reyskens Dairy LLC - November 19, 2013

The FDA issued a Warning Letter to Reyskens Dairy, LLC following a November 19, 2013, investigation of their Custer, Ohio, dairy operation. The letter details multiple violations of the Federal Food, Drug, and Cosmetic Act. A key finding was the sale of an adulterated dairy cow for slaughter, with kidney tissue containing 0.89 ppm of desfuroylceftiofur, exceeding the 0.4 ppm tolerance (21 C.F.R. 556.113(b)(3)(i)), rendering the food adulterated under section 402(a)(2)(C)(ii).

The investigation also revealed that animals were held under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, exemplified by a failure to maintain complete treatment records, violating section 402(a)(4). Furthermore, the firm adulterated the drug Excede by using it extra-label, not as directed by its approved labeling. This extra-label use was not under veterinarian supervision (21 C.F.R. 530.11(a)) and resulted in illegal drug residue (21 C.F.R. 530.11(d)), causing the drug to be unsafe and adulterated under sections 512(a) and 501(a)(5).

Reyskens Dairy is required to take prompt corrective action and establish preventative procedures. A written response detailing these steps, including documentation, is due within fifteen working days. Failure to comply may lead to further regulatory actions like seizure or injunction.