FDA WARNING_LETTER - Archie Domina Farm - July 16, 2012

On July 3, 5, and 16, 2012, the FDA investigated Archie Domina Farm, identifying violations of the Federal Food, Drug, and Cosmetic Act. A bob veal calf sold for slaughter on October 13, 2011, was found to have 0.32 ppm of penicillin in kidney tissue, an unsafe level as FDA has no tolerance for penicillin in veal, rendering the food adulterated under section 402(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, specifically a failure to maintain complete treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under section 402(a)(4).

Furthermore, the new animal drug (b)(4) (Penicillin G Procaine) Injectable was adulterated. It was used extralabelly on bob veal and heifer calves, contrary to approved labeling regarding animal class, dose, frequency, and route of administration. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a) and resulting in an illegal residue, violating 21 C.F.R. 530.11(c). This rendered the drug unsafe under section 512(a) and adulterated under section 501(a)(