FDA WARNING_LETTER - Bliss Dairy, LLC - March 27, 2013

On March 26-27, 2013, the FDA inspected Michael R. Bliss's dairy farm in Delta, Utah, and found violations of the Federal Food, Drug, and Cosmetic Act. The farm offered for sale animals for slaughter as food that were adulterated.

Specifically, a dairy cow sold on October 11, 2012, had flunixin in liver tissue at 0.177 ppm (tolerance 0.125 ppm) and desfuroylceftiofur in kidney tissue at 4.53 ppm (tolerance 0.4 ppm). Another dairy cow sold on November 30, 2012, had penicillin in kidney tissue at 0.132 ppm (tolerance 0.05 ppm). These levels exceed established FDA tolerances, rendering the food adulterated under 21 U.S.C. § 342(a)(2)(C)(ii).

The investigation also revealed insanitary conditions, including a failure to maintain complete treatment records, indicating that medicated animals with potentially harmful drug residues could enter the food supply, which is adulteration under 21 U.S.C. § 342(a)(4).

Furthermore, the new animal drugs (b)(4) were adulterated because they were used extralabelly without following approved labeling for withdrawal periods, route of administration, dose, amount per