FDA WARNING_LETTER - C.R. Melear Corporation - April 09, 2015

On May 18, 2015, the FDA issued a Warning Letter to C.R. Melear Corporation following an investigation of their dairy farm on April 8 and 9, 2015. The FDA found violations of the Federal Food, Drug, and Cosmetic Act.

Specifically, on August 21, 2014, the company sold a dairy cow for slaughter that was adulterated. USDA/FSIS analysis of tissue samples from the cow identified penicillin at 0.111 ppm in the kidney tissue, exceeding the FDA tolerance of 0.05 ppm (21 C.F.R. 556.510). This caused the food to be 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, the company adulterated the new animal drug VetriPen G (penicillin G procaine, NADA 065-505) by using it extralabelly without following approved labeling indications for use and duration of treatment. This extralabel use was not under the supervision of a licensed veterinarian (in violation of