FDA WARNING_LETTER - Belter John Jr dba Ethan Allen Farm - July 18, 2013

On June 26, 28, July 3, and 18, 2013, the FDA inspected Ethan Allen Farm, a dairy operation. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to adulterated animals and drugs.

Specifically, two bob veal calves sold for slaughter on September 10 and 17, 2012, were found to have illegal drug residues. One calf had 9.81 ppm of Neomycin in kidney tissue, exceeding the 7.2 ppm tolerance and an unacceptable level for veal calves. The other calf had Gentamicin detected in kidney tissue, for which no tolerance is established in cattle. These findings render the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The farm also failed to maintain complete treatment records, indicating insanitary conditions where medicated animals with harmful residues could enter the food supply, violating section 402(a)(4) of the FD&C Act.

Furthermore, the farm engaged in extralabel drug use without veterinary supervision, violating 21 CFR Part 530. This included administering oxytetracycline and neomycin (in medicated feed) to bob veal calves, administering lincomycin hydrochloride as an intramammary infusion to lactating dairy cows, and administering Gentamicin Sulfate Solution to a bob veal calf