FDA WARNING_LETTER - Aurora Ridge Dairy, LLC - December 01, 2009

The FDA conducted an investigation of Aurora Ridge Dairy, LLC, owned by William J. Cook, on November 18, 20, and December 1, 2009. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act. Specifically, the firm sold a dairy cow for slaughter on May 18, 2009, which was found to contain desfuroylceftiofur residues in its kidney at 0.61 ppm, exceeding the established tolerance of 0.4 ppm (21 C.F.R. 556.113). This renders the food adulterated under section 402(a)(2)(C)(ii) of the Act. Furthermore, the investigation found that the firm holds animals under inadequate conditions, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under section 402(a)(4) of the Act. A key deficiency noted was the failure to maintain complete treatment records. The FDA requires prompt corrective action to address these violations and establish procedures to prevent recurrence. A written response detailing corrective steps, timelines, and supporting documentation must be submitted within fifteen working days. Failure to comply may lead to regulatory actions such as seizure or injunction.