FDA WARNING_LETTER - Bilow Farms, LLC - January 13, 2011

On January 10 and 13, 2011, the FDA investigated Bilow Farms, LLC, a dairy farm in Malone, New York. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to adulterated animals sold for slaughter and improper drug use.

Specifically, on April 13, 2010, a dairy cow sold by Bilow Farms was found to have ampicillin in its kidney at 0.31 ppm, exceeding the 0.01 ppm tolerance (21 C.F.R. 556.40). On September 7, 2010, a bob veal calf sold by the farm contained gentamicin in its kidney tissue, for which no tolerance is established in veal calves. These findings render the animals adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

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

Furthermore, Bilow Farms adulterated the new animal drug Gentafuse (Gentamicin Sulfate Solution) by using it extralabelly without proper veterinary supervision, violating 21 C.