FDA WARNING_LETTER - Rod McNeal Dairy - March 25, 2014

An FDA investigation conducted from March 18-25, 2014, at Rod McNeal Dairy in Dublin, Texas, revealed significant violations of the Federal Food, Drug, and Cosmetic Act. The firm offered for sale an adulterated animal for slaughter, specifically a cow with ear tag (b)(4), which contained 10.56 ppm of desfuroylceftiofur in its kidney, exceeding the established tolerance of 0.4 ppm (21 C.F.R. 556.113). This rendered the food adulterated under section 402(a)(2)(C)(ii) of the Act. Additionally, the investigation found that animals were held under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, constituting adulteration under section 402(a)(4) of the Act. A specific deficiency noted was the failure to maintain complete treatment records. The FDA deemed the firm's March 26, 2014, response to the Form FDA 483 inadequate, lacking evidence of a new record-keeping system or specific changes. Rod McNeal Dairy is required to take prompt corrective action, establish procedures to prevent recurrence, and notify the FDA in writing within fifteen working days, providing documentation of corrections to avoid further regulatory action such as seizure or injunction.