FDA WARNING_LETTER - Uttecht, Kenneth - May 25, 2011

An FDA investigation conducted from May 23-25, 2011, at Uttecht Dairy Farm in Birnamwood, Wisconsin, confirmed the sale of adulterated animals for slaughter. The firm offered animals for sale as food that contained illegal drug residues, violating sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act. Specifically, a veal calf sold in December 2010 contained neomycin at 14.91 ppm in kidney tissue, exceeding the 7.2 ppm tolerance (21 CFR 556.430). Another veal calf sold in March 2011 had neomycin at 124.54 ppm and penicillin at 0.07 ppm in kidney tissue, surpassing tolerances of 7.2 ppm (21 CFR 556.430) and 0.05 ppm (21 CFR 556.510), respectively. These findings indicate a critical failure in the firm's quality system. The investigation also revealed that the farm holds animals under inadequate conditions, making it likely that medicated animals with harmful drug residues enter the food supply. The firm lacks an adequate system to ensure proper drug withdrawal times, including failing to maintain drug treatment records, lacking an adequate drug inventory system, and lacking a system for identifying animals for sale. These systemic deficiencies lead to adulterated food under 21 U.S.C. § 342(a)(4). Uttecht Dairy Farm must take prompt action to correct these violations and implement procedures to prevent recurrence. A written response detailing corrective actions and timelines is required within 15 working days to avoid further regulatory action, such as seizure or injunction.