FDA WARNING_LETTER - Graham Farms, Inc. - January 15, 2015

On January 13-15, 2015, the FDA inspected Graham Companies' dairy farm in Moore Haven, Florida, and found violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on July 17, 2014, Graham Companies sold a dairy cow for slaughter that was found to have penicillin residues of 0.201 ppm in its kidney, exceeding the FDA tolerance of 0.05 ppm (21 C.F.R. 556.510). This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

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 section 402(a)(4) of the FD&C Act.

Furthermore, Graham Companies adulterated the new animal drug Bactracillin G (Penicillin G Procaine, NADA 065-010) by using it extralabelly without following the approved labeling's withdrawal time or complying with 21 C.F.R. Part 530, including the requirement for a valid veterinarian/client/patient relationship. This extralabel use resulted in an illegal drug residue, violating 21 C.F.R. 5