FDA WARNING_LETTER - Rusty Knoll Farm, Inc - April 25, 2013

On July 3, 2013, the FDA issued a Warning Letter to Rusty Knoll Farm, Inc. following an investigation on April 19 and 25, 2013, at their dairy operation in Gorham, Maine. The investigation revealed multiple violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, a dairy cow sold for slaughter on September 17, 2012, was found to have adulterated tissues. USDA/FSIS analysis identified desfuroylceftiofur (a ceftiofur metabolite) at 3.71 ppm in kidney tissue, exceeding the 0.4 ppm tolerance (21 C.F.R. 556.113), and flunixin at 0.398 ppm in liver tissue, exceeding the 0.125 ppm tolerance (21 C.F.R. 556.286). This constitutes adulteration under section 402(a)(2)(C)(ii) of the FD&C Act.

The FDA also found that animals were held under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, specifically due to a failure to maintain treatment records. This is adulteration under section 402(a)(4) of the FD&C Act.

Furthermore, the firm adulterated new