FDA WARNING_LETTER - Three L Farm - September 26, 2013

On September 16, 19, and 26, 2013, the FDA inspected Three L Farm, operated by Gary A. Lashway, Chad A. Lashway, and Brad J. Lashway. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act related to the sale of adulterated animals for slaughter. Specifically, two bob veal calves sold on March 26, 2013, and April 10, 2013, were found to have illegal drug residues. USDA/FSIS analysis identified desfuroylceftiofur, a metabolite of ceftiofur, in kidney tissues at 11.24 ppm and 3.62 ppm, respectively. These levels significantly exceed the established tolerance of 0.4 ppm for ceftiofur residues in cattle kidney tissue, as codified in 21 C.F.R. 556.113. This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act. Furthermore, the FDA found that Three L Farm held animals under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, which constitutes adulteration under section 402(a)(4) of the FD&C Act. A key deficiency noted was the failure to maintain complete treatment records. The firm is responsible for ensuring its overall operation and distributed food comply with the law. Three L Farm must take prompt corrective action and establish procedures to prevent recurrence of these violations. A written response detailing corrective steps, timelines, and supporting documentation is required within fifteen working days to avoid potential regulatory actions such as seizure or injunction.