FDA WARNING_LETTER - Rex L. Jessee - September 04, 2014

On September 3-4, 2014, the FDA investigated Rex L. Jessee's cattle operation in New Tazewell, Tennessee, identifying violations of the Federal Food, Drug, and Cosmetic Act.

The primary violation involved the sale of an adulterated cow for slaughter on February 18, 2014. USDA/FSIS analysis of liver tissue from this animal, slaughtered on February 19, 2014, revealed 0.229 ppm of sulfamethazine. This level exceeds the FDA tolerance of 0.1 ppm for sulfamethazine in cattle liver, rendering the food adulterated under Section 402(a)(2)(C)(ii) of the Act [21 USC 342(a)(2)(C)(ii)].

Additionally, the investigation found that animals were held under insanitary conditions, making it likely that medicated animals with harmful drug residues could enter the food supply. Specifically, Mr. Jessee failed to maintain treatment records, which constitutes adulteration under Section 402(a)(4) of the Act [21 USC 342(a)(4)].

Mr. Jessee is responsible for ensuring compliance and must take prompt action to correct these violations and prevent recurrence. Failure to comply may result in regulatory actions like seizure or injunction. A written response detailing corrective actions and timelines is required within 15 working days to Kimberly A.