FDA WARNING_LETTER - Bezon Farms Inc - September 29, 2014

On September 2-29, 2014, the FDA inspected Bezon Farms Inc., a dairy operation in Elba, New York. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to adulterated food and drugs.

Specifically, on March 10, 2014, Bezon Farms sold a bob veal calf for slaughter. USDA/FSIS analysis of the calf's kidney tissue found florfenicol and sulfamethoxazole residues, for which FDA has no established tolerance in veal. This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

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

Furthermore, Bezon Farms adulterated the new animal drug (b)(4) (florfenicol), NADA (b)(4), by using it extralabel without following approved labeling for animal class. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a), and resulted in illegal drug residues, violating 21 C.F.R.