FDA WARNING_LETTER - Thompson Feedlot & Farms - March 22, 2013

On February 14, 15, 20, and March 22, 2013, the FDA inspected Thompson Feedlot and Farms in Byers, Colorado. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act. Specifically, the new animal drug (b)(4) (sulfadimethoxine) Injection - (b)(4) was adulterated because it was not used as directed by its approved labeling. This constituted an extralabel use, as defined by 21 C.F.R. 530.3(a).

The extralabel use of approved animal or human drugs is permitted only if it complies with sections 512(a)(4) and (5) of the FD&C Act and 21 C.F.R. Part 530, which requires use by or on the lawful order of a licensed veterinarian within a valid veterinarian/client/patient relationship. The investigation found that the drug was administered to sheep without following species-specific directions on the approved labeling, and this extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a). This non-conforming use rendered the drug unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act.

The FDA acknowledged an und