FDA WARNING_LETTER - B & C Calves/Livestock - August 11, 2008

On November 26, 2008, the FDA issued a Warning Letter to B & C Calves/Livestock, owned by Carol A. Weyandt, following an August 11, 2008, inspection of their Claysburg, Pennsylvania, operation. The inspection confirmed a bob veal calf sold around January 25, 2008, for human food was adulterated.

USDA/FSIS analysis of the calf's kidney tissue revealed 15.07 ppm of neomycin, for which FDA has not established a tolerance in veal calf kidney tissue. This presence of neomycin renders the food adulterated under Section 402(a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 342(a)(2)(C)(ii)].

The letter emphasizes that as an animal dealer, B & C Calves/Livestock shares responsibility for introducing adulterated animals into interstate commerce. To prevent future violations, the FDA recommends implementing systems for animal identification and traceability to the source, determining medication history from the source, and establishing appropriate drug withdrawal periods before slaughter. If an animal is medicated and not held, it should be clearly identified and sold as such, not for human consumption.

B & C Calves/Livestock must respond in writing within fifteen working days, detailing corrective actions taken or planned to achieve compliance and