FDA WARNING_LETTER - Petrie Farms - July 29, 2014

On July 16 and 29, 2014, the FDA inspected Petrie Farms, a dairy operation in Arcade, New York. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on December 2, 2013, Petrie Farms sold a bob veal calf for slaughter. Post-slaughter analysis by USDA/FSIS found 1.3 ppm of desfuroylceftiofur (ceftiofur marker residue) in the kidney, exceeding the FDA tolerance of 0.4 ppm. This rendered the animal's tissue adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The FDA also found that animals were held under insanitary conditions, increasing the likelihood of drug residues entering the food supply, specifically due to a failure to maintain complete treatment records. This constitutes adulteration under 21 U.S.C. § 342(a)(4).

Furthermore, the new animal drug Excenel RTU EZ (ceftiofur hydrochloride) was adulterated. The investigation revealed extralabel use of Excenel RTU EZ on a bob veal calf without following approved labeling or a veterinary prescription. This extralabel use was not under the supervision of a licensed veterinarian (violating 21 C.F.R. 530.11(a)) and resulted