FDA WARNING_LETTER - Valley Mead Farms LLC - May 12, 2014

On April 28 and May 12, 2014, the FDA investigated Valley Mead Farms, LLC, identifying violations of the Federal Food, Drug, and Cosmetic Act. A dairy cow sold for slaughter on December 2, 2013, was found to have adulterated tissue. USDA/FSIS analysis revealed sulfadimethoxine residues at 1.14 ppm in liver and 0.763 ppm in muscle, exceeding the 0.1 ppm tolerance, and flunixin residues at 0.656 ppm in liver, exceeding the 0.125 ppm tolerance. This constitutes adulteration under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also found insanitary conditions, including a failure to maintain complete treatment records (e.g., withhold times, dose, route, responsible person), leading to potential harmful drug residues in the food supply, violating 21 U.S.C. § 342(a)(4).

Furthermore, the firm adulterated new animal drugs (sulfadimethoxine injection 40%, sulfadimethoxine bolus, flunixin meglumine injectable solution, and penicillin G procaine injectable suspension) by using them extralabelly without veterinary supervision or in violation of approved labeling, and resulting in illegal drug residues. Specific instances included administering sulfadimethoxine without following approved