FDA WARNING_LETTER - Bradley D Spear

On March 17, 2011, the FDA conducted an investigation of Bradley D. Spear's cattle farm in Glasgow, KY, identifying violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of an adulterated cow for slaughter on October 25, 2010. Tissue analysis by USDA/FSIS revealed gentamicin in the kidney and sulfamethazine at 2.78 parts per million (PPM) in the liver. This exceeded the established tolerance of 0.1 PPM for sulfamethazine (21 C.F.R. § 556.640) and violated the absence of a tolerance for gentamicin (21 C.F.R. § 556.300), rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

Additionally, the investigation found that animals were held under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, which constitutes adulteration under 21 U.S.C. § 342(a)(4). Specific deficiencies included failure to maintain treatment records, a drug inventory system, and to inquire about the medication status of purchased animals. Mr. Spear is required to take prompt corrective action and establish procedures to prevent recurrence. A written response detailing these steps, including timelines and documentation, must be submitted within fifteen working days. Failure to comply may result in regulatory actions such as seizure or injunction.