FDA WARNING_LETTER - Wesley Bourcy - April 29, 2013

On April 16, 22, 23, and 29, 2013, the FDA inspected Wesley A. Bourcy's dairy operation in Cape Vincent, New York. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on February 4, 2013, a bob veal calf sold for slaughter was found to have 9.64 ppm of neomycin in kidney tissue, exceeding the 7.2 ppm tolerance and having no acceptable level for bob veal calves. This rendered the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The operation also held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, violating section 402(a)(4). Deficiencies included failure to maintain complete treatment records, identify treated bob veal calves, and implement a system for controlling drug administration.

Furthermore, the new animal drug (b)(4) Scours & Pneumonia Treatment Type B Medicated Feed (neomycin sulfate and oxytetracycline hydrochloride) was adulterated. The drug was used extralabelly by administering it to a bob veal calf, which is not the approved animal class, and without a valid veterinarian/client/patient relationship. This extralabel use in feed and resulting illegal residue violated 21 C.F.R. 5