FDA WARNING_LETTER - Joseph Timothy Smart - December 19, 2014

On December 18 and 19, 2014, the FDA inspected Joseph Timothy Smart Dairy, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of an adulterated dairy cow for slaughter on July 1, 2014. Tissue analysis by USDA/FSIS revealed 16.54 parts per million (ppm) of desfuroylceftiofur in the animal's kidney tissue, far exceeding the established tolerance of 0.4 ppm (21 C.F.R. 556.113). This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act. Furthermore, the investigation uncovered that the dairy holds animals under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply. Specific deficiencies included a failure to maintain treatment records and the presence of expired drugs in inventory, leading to adulteration under section 402(a)(4) of the FD&C Act. The FDA requires prompt corrective action to address these violations and establish procedures to prevent recurrence. A written response detailing these steps is due within fifteen working days. Failure to comply may result in further regulatory actions, such as seizure or injunction.