FDA WARNING_LETTER - Amos Conley Farms - May 10, 2013

The FDA conducted an inspection of Amos Conley Farms, a dairy farm, in April and May 2013, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of a dairy cow for slaughter with kidney tissue containing 5.41 ppm of desfuroylceftiofur, a ceftiofur metabolite, significantly exceeding the 0.4 ppm tolerance (21 C.F.R. 556.113). This rendered the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii). Further, the farm was found to hold animals under insanitary conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, partly due to a failure to maintain treatment records, violating 21 U.S.C. 342(a)(4). The new animal drug Ceftflex was also found to be adulterated due to improper extralabel use. Specifically, Ceftflex was administered without licensed veterinarian supervision (21 C.F.R. 530.11(a)) and resulted in an illegal drug residue (21 C.F.R. 530.11(d)). These extralabel uses caused the drug to be unsafe and adulterated under 21 U.S.C. 360b(a) and 21 U.S.C. 351(a)(5). Amos Conley Farms is required to take prompt corrective action to address these violations and implement procedures to prevent recurrence. A written response detailing these steps, including documentation, is due within fifteen working days. Failure to comply may lead to regulatory actions such as seizure or injunction.