FDA WARNING_LETTER - Papas Dairy LLC - August 08, 2014

On July 29, August 5 and 8, 2014, the FDA inspected Papas Dairy LLC, located at 322 Wheeler Road, North Bangor, New York. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on or about March 13, 2014, Papas Dairy LLC sold a bob veal calf for slaughter, which was found to contain tulathromycin residue in kidney tissue at levels exceeding the established tolerance for cattle, and for which there is no acceptable level for veal calves. This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found that animals were held under insanitary conditions, including a failure to maintain complete treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act.

Furthermore, Papas Dairy LLC adulterated the new animal drug (b)(4), NADA (b)(4), by using it extralabelly without following the approved labeling for animal class. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a), and resulted in an illegal drug residue, violating 21 C.F.R