FDA WARNING_LETTER - Ashland Farm, LLC - July 22, 2014

On July 15 and 22, 2014, the FDA inspected Ashland Farm LLC's dairy operation in Aurora, New York, and found violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The primary violation was offering for sale an adulterated animal for slaughter. Specifically, a bob veal calf sold around (b)(4) and slaughtered around (b)(4) contained gamithromycin in its kidney tissue, for which FDA has not established a tolerance in calves. This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, the FDA found that Ashland Farm LLC 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, the new animal drug (b)(4) (gamithromycin) was adulterated because it was used extralabelly without following approved labeling for animal class and withdrawal period. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a), and resulted in an illegal drug residue, violating 21 C.F.R. 530.11(c). This caused the drug