FDA WARNING_LETTER - South Fork Farms, LLC - May 28, 2015

On May 14, 18, and 28, 2015, the FDA investigated South Fork Farms, LLC, a dairy operation. The investigation revealed several violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on September 8, 2014, South Fork Farms sold a dairy cow for slaughter that was found to be adulterated. USDA/FSIS analysis of tissue samples from this animal identified 2.31 ppm of desfuroylceftiofur in kidney tissue (tolerance 0.4 ppm) and 1.25 ppm of flunixin residue in liver tissue (tolerance 0.125 ppm). These levels exceed established tolerances, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found that animals were held under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, violating section 402(a)(4) of the FD&C Act. This was evidenced by the failure to maintain complete treatment records for cows and bulls, and no treatment records for calves.

Furthermore, the new animal drug Flunixin Injection was adulterated under section 501(a)(5) of the FD&C Act because it was used extralabelly without following approved labeling or a veterinarian's prescription. Specifically, Flunixin