FDA WARNING_LETTER - Valmont Dairy LLC - February 10, 2011

On February 8-10, 2011, the FDA inspected Valmont Dairy, LLC, identifying violations of the Federal Food, Drug, and Cosmetic Act. A bob veal calf sold for slaughter on August 5, 2010, was found to have sulfamethoxazole residues in the liver (0.483 ppm) and muscle (0.669 ppm), for which FDA has no established tolerance, rendering the food adulterated under 21 U.S.C. 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, specifically a failure to maintain complete treatment records, making it likely that medicated animals with harmful drug residues could enter the food supply, thus adulterating food under 21 U.S.C. 342(a)(4).

Furthermore, the human drugs sulfamethoxazole and trimethoprim, contained in "Tribrissen 960 mg," were used extralabelly without following the veterinarian's prescribed withhold period and without licensed veterinarian supervision, violating 21 C.F.R. 530.11(a) and resulting in an illegal residue, violating 21 C.F.R. 530.11(c). This rendered the drugs unsafe under 21 U.S.C. 360b(a) and adulterated under