FDA WARNING_LETTER - Gregory S. Stone - September 23, 2015

On September 16 and 23, 2015, the FDA inspected Gregory S. Stone's cattle farm in Austinville, Virginia, and found violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, a beef cow sold for slaughter on January 29, 2015, was found to have sulfamethazine in its liver at 38.14 ppm, exceeding the FDA tolerance of 0.1 ppm. This rendered the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also revealed insanitary conditions, leading to adulterated food under section 402(a)(4) of the FD&C Act. Deficiencies included: * Failure to maintain treatment records. * Failure to maintain records identifying transported and sold animals. * Lack of an adequate drug inventory system. * Holding expired drugs.

Furthermore, the new animal drug Sustain III (sulfamethazine antibacterial) was used in an extralabel manner without following the withdrawal period and without the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a) and (d). This caused the drug to be unsafe and adulterated under sections 512(a) and 510(a)(5) of the FD&C Act.

Stone