Watson Dairy – FDA Warning Letter, Mar 20, 2013

On March 13 and 19-20, 2013, the FDA investigated Watson Dairy in Sweetwater, Tennessee, and found violations of the Federal Food, Drug, and Cosmetic Act. A cow sold for slaughter on December 5, 2012, was found to be adulterated. USDA/FSIS analysis of tissue samples from this animal, slaughtered on December 6, 2012, revealed 0.315 ppm of penicillin in kidney tissue and 0.442 ppm of flunixin in liver tissue. These levels exceed the FDA tolerances of 0.05 ppm for penicillin and 0.125 ppm for flunixin in cattle tissues, rendering the food adulterated under Section 402(a)(2)(C)(ii) of the Act.

The investigation also found that animals were held under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, thus adulterating food under Section 402(a)(4). Specifically, the dairy failed to maintain treatment records.

Furthermore, the new animal drugs Norocillin (penicillin G procaine) and Flunixin Meglumine were adulterated under Section 501(a)(5) because they were used extralabelly without the supervision of a licensed veterinarian, violating 21 CFR 530.11(a). Norocillin