FDA WARNING_LETTER - Troyer Farms - March 10, 2010

On March 9 and 10, 2010, the FDA inspected Troyer Farms, a dairy operation in Laotto, Indiana. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on August 11, 2009, Troyer Farms sold a dairy cow for slaughter that was found to be adulterated. USDA/FSIS analysis of tissue samples from this animal, slaughtered on August 12, 2009, identified 1.0512 ppm of flunixin in the liver, exceeding the FDA tolerance of 0.125 ppm (21 C.F.R. 556.286). Gentamicin residue was also found in the kidney tissue, for which FDA has no established tolerance. This constitutes adulteration under section 402(a)(2)(C)(ii) of the Act.

The investigation also found that Troyer Farms held animals under insanitary conditions, failing to maintain treatment records, which could lead to medicated animals with harmful drug residues entering the food supply. This is adulteration under section 402(a)(4) of the Act.

Furthermore, Troyer Farms adulterated the new animal drug gentamicin sulfate by using it extralabelly without following approved labeling or veterinarian's instructions, and not under veterinary supervision, violating 21 C.F.R. 530.