FDA WARNING_LETTER - Lisbon Centre Farms - June 03, 2011

On May 23, 25, and June 3, 2011, the FDA inspected Lisbon Centre Farms, a dairy farm in Lisbon, New York. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, on October 6, 2010, the farm sold a bob veal calf for slaughter. Tissue analysis by USDA/FSIS on October 7, 2010, found 0.155 ppm of flunixin in the liver, for which FDA has no established tolerance in veal calves. This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The farm also 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 complete treatment records. This constitutes adulteration under section 402(a)(4) of the FD&C Act.

Furthermore, the new animal drug flunixin meglumine was adulterated because it was used extralabelly without following approved labeling for the 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. 53