FDA WARNING_LETTER - Leroy C. Wormell, Jr. and Son, Inc. - May 03, 2013

On July 3, 2013, the FDA issued a Warning Letter to Leroy C. Wormell, Jr. and Son, Inc. following an inspection from April 4 to May 3, 2013. The inspection confirmed that a dairy cow purchased, hauled, and sold by the company on or about September 18, 2012, for slaughter for human food, was in violation of Section 402(a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act.

Tissue samples from the slaughtered animal, analyzed by USDA/FSIS, revealed desfuroylceftiofur at 3.71 ppm in kidney tissue and flunixin at 0.398 ppm in liver tissue. These levels exceed the FDA's established tolerances of 0.4 ppm for desfuroylceftiofur in cattle kidney (21 C.F.R. 556.113) and 0.125 ppm for flunixin in cattle liver (21 C.F.R. 556.286), rendering the food adulterated.

The FDA requires prompt corrective action to prevent recurrence, warning of potential regulatory actions like seizure or injunction. As an animal dealer, the company shares responsibility for introducing adulterated animals into interstate commerce. To avoid future violations, the FDA recommends implementing systems for animal traceability, determining