FDA WARNING_LETTER - Pine Groves Farm Ltd. - March 16, 2011

On March 10 and 16, 2011, the FDA investigated Pine Groves Farm, a cattle operation located at 2552 Fig Avenue, Doon, Iowa. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act. Specifically, on or about January 19, 2011, Pine Groves Farm sold a cow for slaughter that was found to be adulterated.

Analysis of liver tissue from this animal by the USDA/FSIS identified 0.159 ppm of flunixin. This level exceeds the FDA's established tolerance of 0.125 ppm for flunixin residues in cattle liver, as codified in 21 C.F.R. § 556.286. This presence of flunixin 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)].

Pine Groves Farm is responsible for ensuring compliance with the law. Prompt corrective actions are required to prevent recurrence of these violations. Failure to comply may result in regulatory actions such as seizure and/or injunction. The FDA acknowledged receipt of a response to the FDA-483, outlining proposed