FDA WARNING_LETTER - Pork Champ, LLC - December 01, 2011

On November 29 through December 1, 2011, the FDA inspected Pork Champ, LLC's hog farm in Lucasville, OH. The inspection revealed a violation of the Federal Food, Drug, and Cosmetic Act. Specifically, on or about August 15, 2011, Pork Champ, LLC sold a sow (ear tag #4300) for slaughter that was adulterated. USDA/FSIS analysis of tissue samples from this sow found 1.5 ppm penicillin in the kidney. This violates 21 CFR Part 556.510(b), which sets a ZERO tolerance for penicillin residue in edible swine tissue. This makes the food adulterated under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. 342(a)(2)(C)(ii), as it contained an unsafe new animal drug. Pork Champ, LLC is responsible for ensuring compliance and preventing recurrence. The company must respond in writing within fifteen working days, detailing corrective actions taken or planned, including a timeline if actions cannot be completed within 15 days. Failure to comply may result in regulatory actions like seizure or injunction.