FDA WARNING_LETTER - Swiss Hill Farm - September 29, 2015

On September 25 and 29, 2015, the FDA investigated Swiss Hill Farm's dairy operation. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on May 13, 2015, Swiss Hill Farm sold a bob veal calf for slaughter. USDA/FSIS analysis of tissue samples from this animal, slaughtered on May 15, 2015, identified neomycin at 13.06 ppm in the kidney. This exceeds the FDA tolerance of 7.2 ppm for neomycin in uncooked edible tissues of cattle (21 C.F.R. 556.430) and is considered an illegal residue for veal calves, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Furthermore, the drug (b)(4) was adulterated because it was used in an extralabel manner, specifically administered to a bob veal calf without following the animal class stated in its approved labeling. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a), and resulted in an illegal drug residue, violating 21 C.F.R. 530.11(c). This caused the drug to be unsafe under section 512(