FDA WARNING_LETTER - Himmelspach, William W. - August 30, 2013

On August 30, 2013, the FDA investigated a dealer/hauler operation in Timber, Oregon. The investigation confirmed that a bob veal calf sold around April 9, 2013, for human consumption, was adulterated under section 402(a)(2)(C)(ii) of the FD&C Act. USDA/FSIS analysis found flunixin in kidney tissue and sulfamethazine at 222.76 ppm in liver tissue and 119.96 ppm in muscle tissue. Flunixin is not permitted in veal calves, and sulfamethazine exceeded the 0.1 ppm tolerance (21 C.F.R. 556.670).

The letter states the dealer is responsible for ensuring compliance and preventing recurrence. To avoid future violations, the FDA recommends implementing systems to: identify purchased animals for traceability, determine medication history from the source, and withhold medicated animals from slaughter for appropriate withdrawal periods or clearly identify them as medicated and not for human food. The firm must respond in writing within fifteen working days, detailing corrective actions taken or planned, including documentation, or explain any delays and provide a timeline. Failure to comply may result in regulatory action like seizure or injunction.