FDA WARNING_LETTER - Dueppengeisser Dairy Company - April 11, 2014

On April 1 and 11, 2014, the FDA inspected Dueppengeisser Dairy Company, located in Perry, New York, and found violations of the Federal Food, Drug, and Cosmetic Act.

The company sold a bob veal calf for slaughter that was adulterated, as USDA/FSIS analysis identified tulathromycin in kidney tissue, for which FDA has no established tolerance in bob veal calves. This violates section 402(a)(2)(C)(ii) of the FD&C Act.

Furthermore, the investigation revealed insanitary conditions, specifically a failure to maintain complete treatment records for calves, lacking drug dosage, administration route, withdrawal times, and administrator. This causes food to be adulterated under section 402(a)(4) of the FD&C Act.

The company also adulterated new animal drugs, Tulathromycin and Ceftiofur Crystalline Free Acid, by using them extralabelly without veterinary supervision, violating 21 C.F.R. 530.11(a). The extralabel use of Tulathromycin resulted in an illegal drug residue, violating 21 C.F.R. 530.11(c). The extralabel use of Ceftiofur Crystalline Free Acid is prohibited in cattle, specifically above recommended dosages and in calves for veal, violating 21 C.F.R. 530.