William Rausch – FDA Warning Letter, Apr 29, 2014

On April 22 and 29, 2014, the FDA investigated R Style Holsteins, a dairy operation in Edison, Ohio. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, on January 17, 2014, R Style Holsteins sold a dairy cow for slaughter that was found to be adulterated. Tissue samples from the animal, analyzed by USDA/FSIS, showed 0.193 ppm of flunixin in the liver, exceeding the FDA tolerance of 0.125 ppm (21 C.F.R. 556.286(b)(1)(i)). Additionally, 0.056 ppm of penicillin was found in the kidney, which, while below the 0.50 ppm tolerance (21 C.F.R. 556.510(a)), contributed to the adulteration under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found that the operation held animals under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, constituting adulteration under section 402(a)(4) of the FD&C Act. A specific deficiency noted was the failure to maintain complete treatment records.

R Style Holsteins is required to take prompt