Lewis Livestock & Veal Company – FDA Warning Letter, Jun 18, 2012

On August 16, 2012, the FDA issued a Warning Letter to Lewis Livestock & Veal Company following an investigation conducted on May 23, 25, and June 15, 18, 2012. The investigation revealed that seven bob veal calves offered for slaughter as food were adulterated under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), due to unsafe new animal drug residues.

Specifically, two calves sold on September 25, 2011, and February 1, 2012, contained sulfamethoxazole in liver and muscle tissue, a human drug with no established safe tolerance level in cattle. One calf sold on November 27, 2011, had flunixin in liver tissue, for which no tolerance is established in pre-ruminating veal calves. Four calves sold on December 8, 9, 12, and 23, 2011, contained neomycin in kidney tissue exceeding the established tolerance of 7.2 ppm (21 C.F.R. 556.430).

The FDA requires prompt corrective action to prevent recurrence, warning of potential regulatory actions like seizure or injunction. As an animal dealer,