FDA WARNING_LETTER - Lapp, John - February 22, 2010

On February 22, 2010, the FDA investigated John K. Lapp's dairy operation in Allenwood, Pennsylvania, and found violations of the Federal Food, Drug, and Cosmetic Act.

The primary violation involved the sale of an adulterated bob veal calf for slaughter on June 8, 2009. USDA/FSIS analysis of liver tissue from this calf, slaughtered on June 9, 2009, revealed 0.1013 ppm of flunixin. Since FDA has not established a tolerance for flunixin residues in veal calves, this presence renders the food adulterated under section 402(a)(2)(C)(ii) of the Act.

The investigation also found that animals were held 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 Act.

Furthermore, the new animal drug flunixin meglumine (Flu-Nix D) was adulterated. Mr. Lapp used Flu-Nix D extralabelly by administering it to a veal calf, a class of animal not specified on the approved labeling, and without a licensed veterinarian's extralabel use directions, violating 21 C.F.R. 530.11(a). This extralabel use