FDA WARNING_LETTER - Randall A. Ooms, Oomsview Holsteins - September 17, 2014

The FDA issued a Warning Letter to Oomsview Holsteins following an inspection on September 9 and 17, 2014, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved offering for sale an adulterated animal for slaughter. Specifically, a cow sold on May 29, 2014, was found to have 8.25 ppm of desfuroylceftiofur in its kidney tissue, significantly exceeding the FDA tolerance of 0.4 ppm (21 C.F.R. 556.113(b)(3)(i)), rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act. Furthermore, the investigation revealed that Oomsview Holsteins holds animals under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, which constitutes adulteration under section 402(a)(4) of the FD&C Act. Specific deficiencies included a failure to maintain complete treatment records and the presence of expired drugs in their inventory. The FDA requires prompt corrective action to address these violations and establish procedures to prevent recurrence. A written response detailing these steps, including documentation and timelines, is due within fifteen working days. Failure to comply may lead to further regulatory actions such as seizure or injunction.