FDA WARNING_LETTER - Luce Dairy Farm - April 08, 2014

On March 19, April 1, and April 8, 2014, the FDA investigated Luce Dairy Farm in Varysburg, New York, and found violations of the Federal Food, Drug, and Cosmetic Act. The farm offered for sale an adulterated bob veal calf for slaughter on July 8, 2013, which was slaughtered on July 9, 2013. USDA/FSIS analysis found 5.87 ppm of sulfamethazine in the liver and 4.06 ppm in the muscle, exceeding the FDA's zero tolerance for sulfamethazine in bob veal calves, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, including failure to maintain treatment records and properly identify/segregate treated animals, leading to potential harmful drug residues entering the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4). Furthermore, the farm illegally used the new animal drug Sulfamethazine Sustained Release Bolus extralabelly by administering it to a bob veal calf without following approved labeling and without licensed veterinary supervision, violating 21 C.F.R. 530.11(a) and resulting in illegal drug residues, violating 21 C.F.R. 530