FDA WARNING_LETTER - Full Circle Dairy, LLC - February 11, 2008

On February 6 and 11, 2008, an FDA inspection of Full Circle Dairy, LLC, revealed multiple violations. The company offered animals for slaughter as food that were adulterated under sections 402(a)(2)(C)(ii) and 402(a)(4) of the Federal Food, Drug, and Cosmetic Act (the Act). Specifically, a dairy cow sold on August 7, 2007, had flunixin in liver tissue at 0.236 ppm, exceeding the 0.125 ppm tolerance (21 CFR 556.286). Another cow sold on June 2, 2007, had penicillin in kidney tissue at 0.11 ppm, exceeding the 0.05 ppm tolerance (21 CFR 556.510).

The inspection also found that the new animal drugs Flunixin Meglumine and Penicillin G Procaine became unsafe under section 512(a) and adulterated under section 501(a)(5) of the Act due to extralabel use not in conformance with approved labeling or under the supervision of a licensed veterinarian, violating 21 CFR 530.11(a) and resulting in illegal residues, violating 21 CFR 530.11(d).

Furthermore, Full Circle Dairy lacked an adequate