FDA WARNING_LETTER - THE MASCHHOFFS, LLC - May 23, 2012

On May 23, 2012, the FDA investigated The Maschhoffs, LLC's hog operation in Carlyle, Illinois, and found a violation of the Federal Food, Drug and Cosmetic Act. The company offered for sale an adulterated animal for slaughter as food. Specifically, on or about November 16, 2011, a cull sow (ear tag # (b)(4)) was sold for slaughter. USDA/FSIS analysis of tissue samples from this animal, slaughtered on November 18, 2011, identified penicillin in the muscle and kidney tissue.

This presence of penicillin renders the food adulterated under Section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), because FDA has not established a tolerance for penicillin residues in uncooked edible swine tissue (21 C.F.R. 556.510). The letter states this is not an exhaustive list of violations and emphasizes the company's responsibility to ensure compliance.

The FDA acknowledged the firm's response and corrective actions implemented during the inspection. The company must notify the FDA in writing within fifteen working days of receiving the letter, detailing steps taken or planned to correct violations and prevent recurrence. Failure to comply may result in regulatory actions like seizure or injunction.