FDA WARNING_LETTER - Michael A Hatcher - September 04, 2014

On September 3 and 4, 2014, the FDA conducted an investigation of Michael A. Hatcher's cattle operation in Columbia, Kentucky, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved the sale of an adulterated dairy cow for slaughter on December 10, 2013. Tissue samples from this animal revealed 0.65 ppm of sulfamethazine in the liver, exceeding the FDA tolerance of 0.1 ppm (21 C.F.R. § 556.670). This rendered the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), due to an unsafe new animal drug. Additionally, the investigation found that animals were held under insanitary 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, 21 U.S.C. § 342(a)(4). Specific deficiencies included a failure to maintain complete treatment records and drug inventory records, indicating poor quality system and compliance. Mr. Hatcher is required to take prompt corrective action, establish preventive procedures, and respond in writing to the FDA within fifteen working days, detailing steps taken or planned, with supporting documentation. Failure to comply may result in regulatory actions like seizure or injunction.