FDA WARNING_LETTER - Moniz Dairy Farm - January 31, 2012

On December 19, 2011, and January 31, 2012, the FDA investigated Moniz Dairy Farm, identifying violations of the Federal Food, Drug, and Cosmetic Act. A bob veal calf sold for slaughter on July 12, 2011, was found to be adulterated. USDA/FSIS analysis revealed 0.4 ppm penicillin in kidney tissue (tolerance 0.05 ppm) and 83.202 ppm sulfamethazine in liver tissue (tolerance 0.1 ppm), violating 21 U.S.C. 342(a)(2)(C)(ii).

The farm also held animals under insanitary conditions, likely leading to drug residues in the food supply, specifically due to a failure to maintain complete treatment records, violating 21 U.S.C. 342(a)(4). Additionally, the new animal drug Agri-Cillin was used extralabelly on a veal calf, a class not specified on the label, and without licensed veterinarian supervision, resulting in illegal residues. This violated 21 C.F.R. 530.11(a) and (d), rendering the drug unsafe and adulterated per 21 U.S.C. 360b(a) and 21 U.S.C. 351(a)(5).