Rausch Farms – FDA Warning Letter, May 27, 2011

On May 25 and 27, 2011, the FDA investigated Rausch Farms, a dairy farm in Athens, WI, and found violations of the Federal Food, Drug, and Cosmetic Act. The farm offered for sale animals for slaughter as food that were adulterated.

Specifically, a dairy cow sold on March 14, 2011, had desfuroylceftiofur at 16.68 ppm in the kidney and flunixin at 0.152 ppm in the liver. Another cow sold on December 6, 2010, had desfuroylceftiofur at 17.58 ppm in the kidney. These levels exceed the FDA tolerances of 0.4 ppm for desfuroylceftiofur in kidney and 0.125 ppm for flunixin in liver, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also revealed insanitary conditions, including a failure to maintain complete treatment records and to systematically review records to ensure withdrawal times were observed before slaughter. This causes food to be adulterated under section 402(a)(4) of the FD&C Act.

Rausch Farms was instructed to take prompt action to correct these violations and establish procedures to prevent recurrence. A written response detailing corrective actions was required within fifteen working