Gomes Dairy – FDA Warning Letter, Aug 15, 2012

On July 17, August 1, and August 15, 2012, the FDA investigated Gomes Dairy in Hilmar, California, and found violations of the Federal Food, Drug, and Cosmetic Act. The dairy offered for sale an adulterated animal for slaughter. Specifically, a bob veal calf sold on January 19, 2012, contained sulfamethoxazole residues of 0.993 ppm in the liver and 2.660 ppm in muscle tissue, for which FDA has no established tolerance, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also revealed insanitary conditions, including a failure to maintain complete treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act.

Furthermore, Gomes Dairy adulterated human drug sulfamethoxazole and trimethoprim tablets by using them extralabelly without following the veterinarian's prescribed directions, specifically regarding slaughter withdrawal time. This extralabel use was not under the supervision of a licensed veterinarian (21 C.F.R. 530.11(a)) and resulted in illegal drug residue (21 C.F.R. 530.11(c)), causing the drugs to