FDA WARNING_LETTER - Nutt Dairy - May 16, 2011

On May 10-16, 2011, the FDA inspected Nutt Dairy and found four animals offered for slaughter as food were adulterated. This violates sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act.

Between January 13 and March 23, 2011, four dairy cows consigned for human food contained illegal drug residues. USDA/FSIS analysis revealed Penicillin (0.10-0.12 ppm, tolerance 0.05 ppm), Sulfamethazine (0.78-41.90 ppm, tolerance 0.10 ppm), and Flunixin (0.126 ppm, tolerance 0.125 ppm) in edible tissues, exceeding established tolerances (21 CFR 556).

The investigation also found inadequate conditions, specifically a failure to maintain an adequate system to ensure medicated animals were withheld from slaughter for appropriate withdrawal periods, and a failure to adequately review treatment records. This indicates a systemic issue where medicated animals with harmful residues are likely to enter the food supply.

Nutt Dairy's May 20, 2011, response to the FDA 483 appears to address concerns. However, the letter requires a written response within fifteen working days detailing corrective actions and recurrence prevention, including documentation.