FDA WARNING_LETTER - Stonegate Farms - October 29, 2014

On October 28-29, 2014, the FDA inspected Stonegate Farms Family Limited Partnership in Muleshoe, Texas, and found violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved selling an adulterated animal for slaughter.

Specifically, on July 1, 2014, Stonegate Farms sold a cow that, upon USDA/FSIS analysis, contained 0.648 ppm of penicillin in the kidney and 9.44 ppm of sulfadimethoxine in the liver. These levels exceed the FDA tolerances of 0.05 ppm for penicillin and 0.1 ppm for sulfadimethoxine in cattle tissues, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, including a failure to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply, thus adulterating food under 21 U.S.C. § 342(a)(4).

Furthermore, Stonegate Farms adulterated new animal drugs by using sulfadimethoxine and penicillin G procaine extralabel without following approved labeling directions or veterinarian supervision, violating 21 C.F.R. Part 530. The extralabel use of sulfadimethoxine in lactating dairy cattle is prohibited (21