FDA WARNING_LETTER - Saemrow Dairy

An FDA investigation, conducted by the Minnesota Department of Agriculture on January 6, 2011, at Saemrow Dairy in Waterville, Minnesota, confirmed that the operation offered animals for slaughter as food that were adulterated. Specifically, a dairy cow consigned on September 17, 2010, was found to have 9.87 ppm Neomycin in kidney tissue, exceeding the established tolerance of 7.2 ppm (21 CFR 556.430(b)(1)). This constitutes adulteration under section 402(a)(2)(C)(ii) of the Federal Food, Drug, and Cosmetic Act. The investigation also revealed that Saemrow Dairy holds animals under conditions that fail to prevent medicated animals bearing potentially harmful drug residues from entering the food supply, leading to adulteration under section 402(a)(4). A key deficiency noted was the failure to maintain treatment records. The FDA requires prompt corrective action to address these violations and establish procedures to prevent recurrence. Saemrow Dairy must respond in writing within 15 working days, detailing corrective steps taken or planned, including documentation, to ensure compliance and avoid further regulatory actions such as seizure or injunction.