FDA WARNING_LETTER - Goodlett Dairy Farm - June 07, 2013

On June 7, 2013, the FDA inspected Goodlett Dairy Farm in Harrodsburg, Kentucky, and identified significant violations of the Federal Food, Drug, and Cosmetic Act. The primary violation involved the sale of an adulterated dairy cow for slaughter on February 26, 2013. Tissue samples from this animal revealed residues of desfuroylceftiofur (a ceftiofur metabolite) at 0.44 ppm in kidney tissue (exceeding the 0.4 ppm tolerance per 21 C.F.R. 556.113), florfenicol at 5.30 ppm in liver and 0.51 ppm in muscle tissue (exceeding 3.7 ppm and 0.3 ppm tolerances respectively per 21 C.F.R. 556.283), and sulfamethazine at 16.62 ppm in liver tissue (exceeding the 0.1 ppm tolerance per 21 C.F.R. 556.670). Additionally, ciprofloxacin and cefazolin were found, for which no tolerances exist. This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act. The inspection also revealed that animals are held under insanitary conditions, making it likely that medicated animals with harmful drug residues could enter the food supply, constituting adulteration under section 402(a)(4). Specific deficiencies contributing to these conditions include failure to maintain treatment records, identify animals, segregate treated animals, and dispose of expired drugs. The firm must take prompt corrective action and respond in writing within fifteen working days, detailing steps taken to correct violations and prevent recurrence, or face potential regulatory actions like seizure or injunction.