FDA WARNING_LETTER - Livestock Investors Inc Ltd d/b/a Bar G Feedyard - February 05, 2015

On February 2-5, 2015, the FDA inspected Johnny E. Trotter's feedlot operation in Summerfield, Texas, and found violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved offering an adulterated animal for slaughter. Specifically, on October 10, 2014, a cow sold for slaughter contained 0.054 ppm of penicillin in its kidney, exceeding the FDA tolerance of 0.05 ppm (21 C.F.R. 556.510). This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Additionally, the investigation revealed that on April 1, 2009, Trotter provided a false certification stating that livestock sold would not have illegal drug residues. Delivering the penicillin-violative cow on October 10, 2014, while this certification was in effect, constitutes a prohibited act under section 301(h) of the FD&C Act.

Trotter is responsible for ensuring overall operation and food distribution compliance. Prompt corrective action is required to prevent recurrence, including establishing procedures. A written response detailing corrective steps and timelines must be submitted to the FDA within fifteen working days, or regulatory action, such as seizure or injunction, may follow.