FDA WARNING_LETTER - Van Ess Dairy LLC - May 10, 2012

On May 7-10, 2012, the FDA inspected VanEss Dairy LLC in Sanborn, IA. The inspection revealed a violation of the Federal Food, Drug, and Cosmetic Act concerning an adulterated animal sold for slaughter. Specifically, on or about December 1, 2011, VanEss Dairy LLC sold a cow (bangle tag # (b)(4)) for slaughter. USDA/FSIS analysis of tissue samples from this animal, slaughtered on or about December 7, 2011, detected penicillin at 0.41 parts per million (PPM) in the kidney tissue. This level exceeds the FDA tolerance of 0.05 PPM for penicillin residues in cattle edible tissues, as codified in 21 C.F.R. § 556.510.

This presence of penicillin renders the food adulterated under section 402(a)(2)(C)(ii) of the Act, 21 U.S.C. § 342(a)(2)(C)(ii), because it contained an unsafe new animal drug under section 512 of the Act. VanEss Dairy LLC is responsible for ensuring compliance and preventing recurrence. The company must respond in writing within fifteen working days of receiving the letter, detailing corrective actions taken or planned, including documentation, to Danial S. Hutchison, Compliance Officer. Failure to comply may result in