FDA WARNING_LETTER - Woody Hill Farms - May 12, 2015

On April 22, 29, and May 12, 2015, the FDA inspected Woody Hill Farms, a dairy operation in Salem, New York. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on September 11, 2014, Woody Hill Farms sold a bob veal calf for slaughter. USDA/FSIS analysis of tissue samples from this animal found sulfadimethoxine in the kidney tissue. The presence of this drug in edible tissue from a calf processed for veal is not permitted, causing the food to be adulterated under 21 U.S.C. 342(a)(2)(C)(ii).

The investigation also found that Woody Hill Farms holds animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply. This is evidenced by the failure to maintain complete treatment records for calves, lacking details such as drug dosage, administration route, withdrawal time, and administrator. This constitutes adulteration under 21 U.S.C. 342(a)(4).

Furthermore, Woody Hill Farms adulterated the new animal drug sulfadimethoxine by using it extralabelly without following approved labeling or a veterinarian's order, and without the supervision of a licensed veterinarian. The extralabel use also resulted in an illegal drug residue, violating 21 C.F.R. 530