FDA WARNING_LETTER - Cowles Farms, LLC - December 11, 2014

On December 5 and 11, 2014, the FDA inspected Cowles Farms, LLC, a dairy farm in Marietta, New York, and found violations of the Federal Food, Drug, and Cosmetic Act. The farm sold a bob veal calf for slaughter on June 10, 2014, which, upon USDA/FSIS analysis on June 12, 2014, contained desfuroylceftiofur at 1.48 ppm in the kidney, exceeding the 0.4 ppm tolerance (21 C.F.R. 556.113(b)(3)(i)), and flunixin in the kidney, which is not permitted for veal calves (21 C.F.R. 522.970). This rendered the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also revealed insanitary conditions, including a failure to maintain complete treatment records, leading to the likelihood of medicated animals with harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act.

Furthermore, the farm adulterated new animal drugs by using them extralabelly without veterinary supervision or adherence to approved labeling/prescriptions. Specifically, drugs were administered at unapproved dosages or to unapproved animal classes