FDA WARNING_LETTER - Rusty Cattle Company - August 29, 2014

The FDA conducted an investigation of Rusty Cattle Company's cattle farm operation in Paul's Valley, Oklahoma, from August 27-29, 2014. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act. Specifically, the firm offered for sale an animal for slaughter as food that was adulterated. Tissue analysis from a cow sold on May 28, 2014, identified penicillin (1.123 ppm), desfuroylceftifur (1.23 ppm), and flunixin (1.56 ppm) in edible tissues, exceeding established FDA tolerance levels (21 C.F.R. 556.510, 556.113, 556.286). This constitutes adulteration under section 402(a)(2)(C)(ii) of the FD&C Act. Furthermore, the investigation found that animals were held under inadequate conditions, increasing the likelihood of medicated animals bearing harmful drug residues entering the food supply, which is adulteration under section 402(a)(4) of the FD&C Act. A key deficiency contributing to this was the firm's failure to maintain treatment records. The FDA requires prompt corrective action to address these violations and establish procedures to prevent recurrence. A written response detailing these steps, including documentation, is required within fifteen working days. Failure to comply may lead to further regulatory actions, including seizure and/or injunction.