FDA WARNING_LETTER - Shawn Bender - March 28, 2014

On March 11, 17, and 28, 2014, the FDA investigated Shawn & Yvonne Bender dairy farm, located at 5930 Lee Road, Glenfield, New York. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, on or about August 12, 2013, the farm sold a dairy cow for slaughter that was found to be adulterated. USDA/FSIS analysis of tissue samples from this animal identified cefazolin in the kidney. The presence of cefazolin, for which FDA has not established a tolerance in dairy cows for human food, renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

Furthermore, the investigation found that animals were held under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, thus adulterating food under section 402(a)(4) of the FD&C Act. This was due to a failure to control drug administration and maintain complete treatment records.

The human drug Cefazolin for Injection, USP, NDC #0781-3451-70, was also found to be adulterated. The farm administered this drug extralabelly to a dairy cow without following the servicing veterinarian's prescription regarding conditions of use and species class (not for milking