FDA WARNING_LETTER - Reiland, James M. - August 10, 2011

On August 9-10, 2011, the FDA inspected James M. Reiland's hauler/grower operation in Appleton, Wisconsin, and found violations of the Federal Food, Drug, and Cosmetic Act. The primary violation was offering for sale animals for slaughter as food that were adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4) of the Act.

Specifically, a calf sold around December 14, 2010, showed illegal residues of flunixin (0.695 ppm in liver), penicillin (0.34 ppm in kidney, exceeding the 0.05 ppm tolerance), and gentamicin (in kidney), for which no tolerances exist in veal calves. Additionally, two other calves sold around February 25, 2011, had neomycin residues of 125.45 ppm and 313.62 ppm in kidney tissue, significantly exceeding the 7.2 ppm tolerance.

The investigation also revealed insanitary conditions, including a lack of a system to ensure purchased animals are not medicated or, if medicated, to ensure appropriate withdrawal times. Furthermore, the operation failed to keep accurate records for animal traceability.

Reiland is required to take prompt action to correct these violations and implement procedures to prevent recurrence. This includes establishing systems to identify purchased animals, trace them to their source