FDA WARNING_LETTER - Bos Dairy LLC - July 07, 2010

The FDA conducted an investigation of Bos Dairy, LLC in Fair Oaks, Indiana, during May, June, and July 2010, revealing significant violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved the sale of an adulterated cow for slaughter on May 18, 2010. Tissue samples from this animal showed sulfadimethoxine residues (0.755 ppm in liver, 0.767 ppm in muscle) far exceeding the 0.1 ppm tolerance (21 C.F.R. 556.640 (b)(1)), rendering the food adulterated under section 402(a)(2)(C)(ii) of the Act. Additionally, the investigation found that Bos Dairy held animals under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply. This included a failure to maintain complete treatment records, causing food to be adulterated under section 402(a)(4) of the Act. The FDA requires prompt corrective action and the establishment of procedures to prevent recurrence. A written response detailing these steps, including documentation and timelines, is due within fifteen working days. Failure to comply may result in regulatory actions like seizure or injunction.