FDA WARNING_LETTER - 3V Dairy - May 13, 2011

The FDA conducted an inspection of 3V Dairy in Roswell, NM, from May 10-13, 2011, identifying significant violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was that 3V Dairy offered animals for sale for slaughter as food that were adulterated. Specifically, tissue samples from a dairy cow sold in May 2010 showed Penicillin and Flunixin residues exceeding FDA tolerances (0.05 ppm for Penicillin, 0.125 ppm for Flunixin in liver), and another cow sold in November 2010 had Penicillin residues above tolerance. These findings render the food adulterated under section 402(a)(2)(C)(ii) of the Act. Furthermore, the investigation revealed that animals were held under inadequate conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, constituting adulteration under section 402(a)(4) of the Act. This was attributed to the firm's failure to maintain an adequate system for withholding medicated animals from slaughter for sufficient drug depletion times. Additionally, 3V Dairy failed to maintain and review complete treatment records for medicated animals. The FDA requires prompt corrective action to address these violations and prevent recurrence. A written response detailing corrective steps, including documentation, is required within fifteen working days. Failure to comply may lead to regulatory actions such as seizure or injunction.