Sunshine Dairy – FDA Warning Letter, Aug 12, 2011

On June 23 and August 12, 2011, the FDA investigated Sunshine Dairy in Andrews, Indiana, and found violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on February 22, 2011, Sunshine Dairy sold a culled dairy cow for slaughter. USDA/FSIS analysis of tissue samples from this animal on February 23, 2011, revealed penicillin, sulfadimethoxine, and flunixin residues. The sulfadimethoxine (0.145 ppm in liver) and flunixin (0.208 ppm in liver) levels exceeded FDA tolerances of 0.1 ppm and 0.125 ppm, respectively, rendering the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found that Sunshine Dairy held animals under insanitary conditions, failing to maintain treatment records, which could lead to medicated animals with harmful drug residues entering the food supply. This constitutes adulteration under section 402(a)(4) of the FD&C Act.

Furthermore, Sunshine Dairy adulterated the new animal drug flunixin meglumine (Prevail, Injectable Solution, ANADA #200-308) by using it extralabelly without following the prescribed route of administration and without the supervision of a licensed veterinarian, violating