FDA WARNING_LETTER - Hilltop Jersey Farm - March 25, 2013

On March 19 and 25, 2013, the FDA investigated Hilltop Jersey Farm, owned by Nico J. De Boer, in Chandler, Texas. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, on November 26, 2012, a bob veal calf sold for slaughter contained sulfamethoxazole in its kidney tissue, for which FDA has no established tolerance in calves. This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Furthermore, the operation was found to hold animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act. An example cited was the failure to maintain treatment records.

The human drug Sulfamethoxazole and Trimethoprim Tablets, USP, was also found to be adulterated under section 501(a)(5) of the FD&C Act. The investigation showed extralabel use of this drug on the bob veal calf without following the prescribed withdrawal period from a servicing veterinarian and without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a) and resulting in an illegal drug residue, violating 21 C.F