Levi M. Lapp – FDA Warning Letter, May 8, 2013

On May 6 and 8, 2013, the FDA inspected Levi M. Lapp's dairy operation in Strasburg, 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 February 18, 2013. USDA/FSIS analysis of tissue samples from this animal, slaughtered on February 20, 2013, revealed sulfamethazine residues of 25.35 ppm in muscle and 25.1 ppm in liver. This significantly exceeds the FDA's tolerance of 0.1 ppm for sulfamethazine in uncooked edible cattle tissues (21 C.F.R. 556.670), and there is no acceptable residue level for Sustain III Calf Bolus (sulfamethazine) in veal calves. This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, the operation was found to hold animals under insanitary conditions, specifically failing to maintain treatment records, which could lead to medicated animals with harmful drug residues entering the food supply. This constitutes adulteration under section 402(a)(4) of the FD&C Act.

Furthermore, the new animal drug Sustain III Calf Bolus (sulfamethazine), NADA 120-61