FDA WARNING_LETTER - Sigel Cattle Company, Inc. - July 19, 2013

On July 12 and 19, 2013, the FDA inspected Sigel Cattle Company Inc.'s cattle operation in Homerville, Ohio. The inspection revealed multiple violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, on March 11, 2013, the company sold a bob veal calf for slaughter that was found to have flunixin in its kidney tissue. FDA has not established a tolerance for flunixin residues in pre-ruminating calves, rendering the animal adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Furthermore, the investigation found insanitary conditions, including a failure to maintain treatment records and identify treated animals, making it likely that medicated animals with harmful drug residues could enter the food supply. This constitutes adulteration under section 402(a)(4) of the FD&C Act.

The company also adulterated the new animal drug Banamine (flunixin meglumine). Banamine was used extralabelly on a bob veal calf, a class of animal not specified on its approved labeling. 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