FDA WARNING_LETTER - 1008 Grinstead Mill Road Dairy - October 14, 2009

On October 6, 7, 8, 13, and 14, 2009, the FDA investigated Mr. Kelly Poynter, Sr.'s dairy operation in Cave City, Kentucky. The investigation found violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on July 6, 2009, a culled dairy cow sold for slaughter was found to be adulterated. USDA/FSIS analysis revealed 35.936 ppm of sulfamethazine in muscle tissue and 32.294 ppm in liver tissue, exceeding the FDA tolerance of 0.1 ppm (21 C.F.R. 556.670). This violates section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. 342(a)(2)(C)(ii).

The operation also held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, violating section 402(a)(4) of the Act, 21 U.S.C. 342(a)(4). A specific deficiency noted was the failure to maintain treatment records.

Furthermore, sulfamethazine was used extra-label, not as directed by its approved labeling, and without a valid veterinarian/client/patient relationship. The extra-