FDA WARNING_LETTER - Northside Farms LLC - March 24, 2011

On March 21-24, 2011, the FDA inspected Northside Farms, LLC, a dairy operation, and identified significant violations of the Federal Food, Drug, and Cosmetic Act. The investigation revealed that the firm offered adulterated animals for slaughter. Specifically, tissue samples from two dairy cows (ear tags (b)(4) and (b)(4)) consigned for slaughter on August 31 and September 3, 2010, showed Flunixin residues in liver tissue (1.12 ppm and 0.315 ppm, respectively), exceeding the established tolerance of 0.125 ppm (21 CFR 556.286). This renders the food adulterated under section 402(a)(2)(C)(ii) of the Act. Furthermore, the firm was found to hold animals under insanitary conditions, increasing the likelihood of medicated animals with harmful drug residues entering the food supply, constituting adulteration under section 402(a)(4). Northside Farms, LLC lacks an adequate system to ensure proper drug withdrawal times for medicated animals and failed to maintain complete treatment records, omitting critical information such as drug used, dosage, administration details, and withdrawal times. The firm's March 31, 2011, response to the FDA 483 was deemed inadequate due to a lack of evidence of implemented corrective actions. Northside Farms, LLC is required to promptly correct all violations, establish preventative procedures, and provide written notification with supporting documentation to the FDA within fifteen working days to avoid potential regulatory actions like seizure or injunction.