FDA WARNING_LETTER - Antonio Resendes - October 28, 2011

On October 14, 18, and 28, 2011, the FDA investigated Antonio Resendes' dairy operation in Bridgeport, Vermont. The investigation found violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, on June 16, 2011, Resendes sold a calf for slaughter that was found to have sulfamethoxazole at 0.055 ppm in its liver tissue by USDA/FSIS. Since FDA has no tolerance for sulfamethoxazole in veal calves, this rendered the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also revealed insanitary conditions, including failure to maintain drug treatment and inventory records, and lack of a system to discard expired drugs. These conditions mean medicated animals with harmful drug residues could enter the food supply, adulterating food under section 402(a)(4) of the FD&C Act.

Furthermore, Resendes adulterated human drugs Sulfamethoxazole and Trimethoprim by using them extralabelly without a licensed veterinarian's supervision, violating 21 C.F.R. 530.11(a) and resulting in an illegal residue, violating 21 C.F.R. 530.11(c). This caused the drug to be unsafe under section