FDA WARNING_LETTER - Suwannee Dairy - June 13, 2012

On August 8, 2012, the FDA issued a Warning Letter to Suwannee Dairy following a June 12-13, 2012, inspection. The letter cited violations of the Federal Food, Drug, and Cosmetic Act.

A dairy cow sold for slaughter on September 21, 2011, was found to have 0.44 ppm of penicillin in kidney tissue, exceeding the 0.05 ppm tolerance (21 C.F.R. 556.510), 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, which could lead to medicated animals with harmful drug residues entering the food supply, thus adulterating food under 21 U.S.C. 342(a)(4).

Furthermore, Suwannee Dairy adulterated the new animal drug Norocillin Injection (penicillin G procaine) through extralabel use. Penicillin was administered to dairy cows without adhering to approved labeling for dose and indications. This extralabel use was not under the supervision of a licensed veterinarian, violating 21 C.F.R. 530.11(a), making the drug unsafe (21 U.S.C. 360b