Don Selph – FDA Warning Letter, Jul 17, 2012

On July 11-13 and July 16-17, 2012, the FDA investigated Don Selph's cattle grower operation in Franklin, Arkansas, identifying multiple violations of the Federal Food, Drug, and Cosmetic Act.

A cow sold for slaughter on February 17, 2012, was found to have 5.941 ppm of sulfamethazine in liver tissue, exceeding the 0.1 ppm tolerance, rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii). The investigation also revealed insanitary conditions, including failure to maintain treatment records and administering expired drugs, leading to adulterated food under 21 U.S.C. 342(a)(4).

Furthermore, Selph engaged in extralabel use of sulfamethazine without a licensed veterinarian's supervision, violating 21 C.F.R. 530.11(a) and resulting in an illegal drug residue, violating 21 C.F.R. 530.11(d). This caused the drug to be unsafe and adulterated under 21 U.S.C. 360b(a) and 21 U.S.C. 351(a)(5).

Selph's July 31, 20