FDA WARNING_LETTER - Mills Dairy Farm LLC - September 11, 2014

On September 8 and 11, 2014, the FDA investigated Mills Dairy Farm, LLC, located at 2166 State Road 60, Perrysville, Ohio. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, on December 5, 2013, Mills Dairy Farm sold a dairy cow for slaughter. USDA/FSIS analysis of tissue samples from this animal, slaughtered on December 6, 2013, showed 3.62 ppm of florfenicol in the muscle and 4.51 ppm in the liver. These levels exceed the FDA tolerances of 0.3 ppm in muscle and 3.7 ppm in liver (21 C.F.R. 556.283), rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, the investigation found that animals were held under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply. An affidavit dated September 11, 2014, admitted failure to record Nuflor Gold administration to a heifer in November 2013. This constitutes adulteration under section 402(a)(4) of the FD&C Act.

Mills Dairy Farm is responsible for ensuring compliance and must take prompt