FDA WARNING_LETTER - Great lakes Cattle Marketing Company, LLC - April 23, 2015

On April 8, 14, and 23, 2015, the FDA inspected Great Lakes Cattle Marketing Co., LLC, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The firm offered an adulterated Holstein bull calf for slaughter, with tissue samples revealing florfenicol and flunixin residues exceeding FDA tolerances (21 C.F.R. 556.283(b) and 556.286(b)), rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii). Furthermore, animals were held under inadequate conditions, making it likely that medicated animals with harmful drug residues would enter the food supply, constituting adulteration under 21 U.S.C. 342(a)(4). Specifically, the firm failed to ensure contract farmers maintained treatment records and segregated treated animals. The company's response to the FDA 483 was deficient, lacking a system for reviewing records before slaughter to ensure proper drug use and withdrawal times, and the provided treatment record omitted meat withdrawal times. Great Lakes Cattle Marketing Co., LLC must promptly correct these violations, establish preventative procedures, and submit a written response within fifteen working days detailing corrective actions and timelines, with supporting documentation. Failure to comply may result in regulatory actions such as seizure or injunction.