FDA WARNING_LETTER - Woodcrest Dairy Llc - January 30, 2014

On January 23 & 30, 2014, the FDA inspected Woodcrest Dairy LLC, identifying violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved the sale of an adulterated bob veal calf for slaughter on July 11, 2013. USDA/FSIS analysis found 8.14 ppm of neomycin residue in the calf's kidney, exceeding the 7.2 ppm tolerance for cattle and having no acceptable level for bob veal calves when using [(b)(4)] Type B Medicated Feed. This rendered the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also revealed insanitary conditions, specifically the failure to maintain complete treatment records for medicated calves, leading to the likelihood of drug-residue-bearing animals entering the food supply, thus adulterating food under section 402(a)(4). Furthermore, the firm engaged in extralabel use of [(b)(4)] medicated feed by administering it to a bob veal calf, an animal class not specified in the approved labeling. This extralabel use was in or on feed, violating 21 C.F.R. 530.11(b), and resulted in an illegal drug residue, violating 21 C.F.R. 530.11(c). This caused the drug