FDA WARNING_LETTER - Slate River Ranch LLC - June 18, 2013

The FDA conducted an investigation of Slate River Ranch, LLC, from June 10-18, 2013, at their Perrin, Texas cattle ranch, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The firm offered for sale an adulterated heifer for slaughter, with tissue analysis revealing florfenicol residues (6.46 ppm in liver, 0.53 ppm in muscle) exceeding FDA tolerances (3.7 ppm and 0.3 ppm, respectively, per 21 C.F.R. 556.283) and sulfamethazine residues (6.90 ppm in liver) exceeding its tolerance (0.1 ppm, per 21 C.F.R. 556.670). This constitutes adulteration under 21 U.S.C. § 342(a)(2)(C)(ii). Furthermore, the investigation found the ranch holds animals under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, rendering food adulterated under 21 U.S.C. § 342(a)(4). A specific deficiency noted was the failure to maintain complete treatment records prior to May 2013. The firm's June 28, 2013, response to the FDA 483 was deemed inadequate, lacking evidence of a new record-keeping system's implementation or personnel training. Slate River Ranch must promptly correct these violations, establish preventative procedures, and provide written notification to the FDA within fifteen working days, including documentation of corrective actions. Failure to comply may lead to regulatory actions like seizure or injunction.