FDA WARNING_LETTER - James A. Gilligan - September 01, 2015

On August 25 and September 1, 2015, the FDA investigated Bellewood Farms' dairy operation in Woodville, New York. The investigation revealed multiple violations of the Federal Food, Drug, and Cosmetic Act.

A bob veal calf sold for slaughter on June 11, 2015, was found to have 9.1 ppm of neomycin residue in its kidney, exceeding the 7.2 ppm tolerance for cattle and having no acceptable level for veal calves, thus rendering the food adulterated under section 402(a)(2)(C)(ii). The farm also 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, adulterating food under section 402(a)(4).

Furthermore, the farm engaged in extralabel use of several new animal drugs, including (b)(4) (neomycin sulfate and oxytetracycline hydrochloride), (b)(4) (ceftiofur sodium), (b)(4) (ampicillin), (b)(4) (flunixin meglumine), and (b)(4) (penicillin G procaine), without following approved labeling for animal class, dosage, indications for use, route of administration, or injection amount per site. These extralabel uses were not under the supervision of a licensed veterinarian, violating 21 C.F.R.