FDA WARNING_LETTER - Herdering, Steven - December 07, 2012

The FDA conducted an investigation of North Oak Dairy on December 6 and 7, 2012, identifying violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was the sale of an adulterated dairy cow for slaughter on August 13, 2012. Tissue analysis by USDA/FSIS revealed desfuroylceftiofur residues at 1.43 ppm in the kidney, significantly exceeding the FDA tolerance of 0.4 ppm (21 CFR 556.113(b)(3)(i)). This constitutes adulteration under section 402(a)(2)(C)(ii) of the Act. Furthermore, the investigation found that the dairy held animals under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, which is adulteration under section 402(a)(4) of the Act. A specific deficiency noted was the failure to ensure proper drug withdrawal times were observed before offering animals for slaughter. The letter emphasizes the firm's responsibility to ensure compliance and requires prompt corrective action. North Oak Dairy must respond in writing within 15 working days, detailing steps taken to correct violations and prevent recurrence, including documentation. Failure to comply may lead to regulatory actions such as seizure or injunction.