FDA WARNING_LETTER - Lester Troyer Farm - August 01, 2011

On July 26, 27, and August 1, 2011, the FDA inspected Lester Troyer Farms, a dairy operation in Apple Creek, Ohio. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on February 24, 2011, Lester Troyer Farms sold a bob veal calf for slaughter that was found to contain sulfamethoxazole residues at 1.063 ppm in muscle tissue and 0.624 ppm in liver tissue. Since FDA has not established a tolerance for sulfamethoxazole in cattle, this renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found that animals were held under insanitary conditions, specifically due to a failure to maintain treatment records, which could lead to medicated animals with harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act.

Furthermore, Lester Troyer Farms adulterated the human drugs sulfamethoxazole and trimethoprim by using them in an extralabel manner without following the withdrawal period stated in the veterinarian's prescribed labeling and without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a) and resulting in an illegal residue, violating 21 C