FDA WARNING_LETTER - Rocklan Farm - August 14, 2013

On August 12 and 14, 2013, the FDA inspected Rocklan Farm in Chateaugay, New York, and found violations of the Federal Food, Drug, and Cosmetic Act. The farm offered for sale an adulterated animal for slaughter. Specifically, on April 22, 2013, a bob veal calf was sold for slaughter, and USDA/FSIS analysis on April 23, 2013, found sulfamethoxazole in its kidney tissue. FDA has no tolerance for sulfamethoxazole residues in veal, rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, including failure to maintain complete treatment records and segregate treated animals, leading to potential harmful drug residues in the food supply, violating 21 U.S.C. 342(a)(4).

Furthermore, the farm adulterated the human drug Sulfamethoxazole and Trimethoprim Tablets (NDC (b)(4)) by using it extralabelly without following the prescribed withdrawal period and without licensed veterinarian supervision, violating 21 C.F.R. 530.11(a) and (c). This extralabel use resulted in an illegal drug residue, making the drug unsafe under 21 U.S.C. 360b