FDA WARNING_LETTER - Carter Farms Inc. - April 20, 2015

On April 14 and 20, 2015, the FDA inspected Carter Farms Inc.'s dairy operation in Plattsburgh, New York. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) related to the sale of an adulterated animal for slaughter and improper drug use.

Specifically, on February 17, 2015, Carter Farms sold a dairy cow for slaughter. USDA/FSIS analysis of tissue samples from this animal, slaughtered on February 18, 2015, showed 1.82 ppm desfuroylceftiofur in kidney tissue, exceeding the FDA tolerance of 0.4 ppm (21 C.F.R. 556.113). This renders the food adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found that Carter Farms held animals under insanitary conditions, failing to maintain complete treatment records, which could lead to medicated animals with harmful drug residues entering the food supply. This constitutes adulteration under section 402(a)(4) of the FD&C Act.

Furthermore, Carter Farms adulterated the new animal drug Excenel RTU EZ (ceftiofur hydrochloride sterile suspension). The drug was used extralabelly without following the approved label's withdrawal time and without the supervision of a