FDA WARNING_LETTER - Stoney Acres Calves - October 08, 2008

On December 24, 2008, the FDA issued a Warning Letter to Stoney Acres Calves following an investigation on October 6 and 8, 2008, at their Shipshewana, Indiana, calf growing operation. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, Stoney Acres Calves offered three adulterated animals for slaughter. On December 26, 2007, a calf sold for slaughter contained 0.152 ppm of flunixin in the liver, exceeding the 0.0125 ppm tolerance. On January 9, 2008, two calves sold for slaughter showed 0.213 ppm of flunixin in the liver of one and 0.07 ppm of penicillin in the kidney of the other, exceeding the 0.05 ppm penicillin tolerance. These levels caused the food to be adulterated under 21 U.S.C. 342(a)(2)(C)(ii).

The FDA also found that animals were held under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, violating 21 U.S.C. 342(a)(4). Treatment records lacked crucial information such as route of administration, dosage, and withdrawal periods.

Furthermore, the new animal drugs penicillin and flunixin were adulter