FDA WARNING_LETTER - Lynn Born - June 12, 2014

On June 11-12, 2014, the FDA investigated Lynn Born's farm in Follett, Texas, identifying violations of the Federal Food, Drug, and Cosmetic Act. The primary issue was the sale of an adulterated beef cow for slaughter on February 25, 2014. USDA/FSIS analysis of tissue samples from this cow revealed 1.67 ppm of sulfamethazine in the liver and 0.054 ppm of penicillin in the kidney, exceeding FDA tolerances of 0.1 ppm and 0.05 ppm respectively (21 C.F.R. 556.670, 21 C.F.R. 556.510). This constitutes adulteration under section 402(a)(2)(C)(ii) of the Act.

Furthermore, the investigation found insanitary conditions, specifically a failure to maintain treatment records for medicated animals, leading to the likelihood of drug-residue-laden animals entering the food supply, which is adulteration under section 402(a)(4). Additionally, on February 25, 2014, Mr. Born provided a false certification stating his livestock did not have illegal drug residues, a prohibited act under section 301(h).

Mr. Born's June 13, 2014, response was deemed