FDA WARNING_LETTER - Timothy R. Nelson - March 16, 2011

The FDA conducted an inspection of Timothy R. Nelson's cattle operation in Doon, Iowa, on March 10-11 and March 16, 2011. The inspection revealed a violation of the Federal Food, Drug, and Cosmetic Act. Specifically, the firm offered for sale an animal for slaughter as food that was adulterated. This adulteration was due to the presence of 0.159 ppm of flunixin in the animal's liver tissue, which exceeds the FDA tolerance of 0.125 ppm for flunixin residues in cattle liver, as codified in 21 C.F.R. § 556.286. This finding renders the food unsafe under section 512 of the Act [21 U.S.C. § 360b] and adulterated under section 402(a)(2)(C)(ii) of the Act [21 U.S.C. § 342(a)(2)(C)(ii)]. As a dealer, Mr. Nelson is responsible for ensuring compliance. The FDA requires prompt corrective action and establishment of procedures to prevent recurrence. A written response detailing these steps, including documentation, is required within fifteen working days. Failure to comply may result in regulatory actions such as seizure or injunction.