FDA WARNING_LETTER - Rock Inn Dairy - April 04, 2013

On April 2 and 4, 2013, the FDA investigated Rock Inn Dairy in Auburndale, Wisconsin, and found violations of the Federal Food, Drug, and Cosmetic Act. The dairy sold a bob veal calf for slaughter on October 22, 2012, which was found to be adulterated. USDA/FSIS analysis of tissue samples from the calf, slaughtered on October 24, 2012, revealed penicillin at 0.824 ppm in kidney tissue and sulfamethazine at 31.64 ppm in liver tissue and 31.514 ppm in muscle tissue. These levels exceed the FDA tolerances of 0.05 ppm for penicillin and 0.1 ppm for sulfamethazine in uncooked edible cattle tissues, and there is no acceptable residue level for these drugs in bob veal calves. This constitutes adulteration under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found that the dairy held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, specifically due to a failure to maintain treatment records. This is adulteration under section 402(a)(4) of the FD&C Act.

Furthermore, the new animal drugs (sulfamethazine) and (penicillin G benzathine and penicillin G procaine) Injectable Suspension were