FDA WARNING_LETTER - Paul Rothermel Livestock - May 09, 2008

On May 9, 2008, the FDA investigated Paul Rothermel Livestock, identifying violations of the Federal Food, Drug, and Cosmetic Act. A bob veal calf sold for slaughter on February 20, 2008, was found to be adulterated. USDA/FSIS analysis on February 21, 2008, revealed flunixin residues of 0.425 ppm in liver and 0.035 ppm in muscle tissue, for which FDA has no established tolerance in calves. This constitutes adulteration under section 402(a)(2)(C)(ii) of the Act [21 U.S.C. 342(a)(2)(C)(ii)].

Additionally, the operation was found to hold animals under insanitary conditions, leading to potential drug residue contamination in the food supply, violating section 402(a)(4) of the Act [21 U.S.C. 342(a)(4)]. Specific deficiencies included the lack of a system to ensure purchased animals sold for slaughter were not medicated, or to enforce appropriate withdrawal periods for medicated animals. The firm also failed to maintain accurate records for animal traceability.

Paul Rothermel Livestock is required to take prompt corrective action and establish procedures to prevent recurrence. A written response detailing steps taken or planned, including timelines and supporting documentation, must be submitted to the FDA within fifteen working