FDA WARNING_LETTER - Noel D. Elmore - August 15, 2014

The FDA conducted an investigation of Noel Elmore Farms, a dairy operation in Glasgow, Kentucky, on August 11, 12, and 15, 2014. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act. Firstly, the firm offered for sale an adulterated dairy cow for slaughter. Tissue samples from this animal showed penicillin residues at 0.215 ppm in the kidney, exceeding the established tolerance of 0.05 ppm (21 C.F.R. 556.510), rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act. Secondly, the investigation found that animals were held under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply. This included failures to maintain complete treatment records, segregate, and identify treated animals, leading to adulterated food under section 402(a)(4) of the FD&C Act. Finally, the firm provided a false Livestock Consignor Certification on July 5, 2011, falsely stating no illegal drug residues, which is a prohibited act under section 301(h) of the FD&C Act. Noel Elmore Farms is responsible for ensuring overall operation and food distribution compliance. The FDA requires prompt corrective action to address these violations and establish preventative procedures. A written response detailing these steps, including documentation and timelines, is due within fifteen working days. Failure to comply may result in regulatory actions like seizure or injunction.