FDA WARNING_LETTER - Caruso Cattle Company, Inc. - March 09, 2012

On March 1 and 9, 2012, the FDA investigated Caruso Cattle Company, Inc., a livestock dealership in Frankfort, New York. The investigation revealed violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, on December 19, 2011, Caruso Cattle Company sold a bull for slaughter. USDA/FSIS analysis of tissue samples from this animal on December 20, 2011, found 5.62 ppm of desfuroylceftiofur in kidney tissue, exceeding the FDA tolerance of 0.4 ppm for ceftiofur residues in cattle (21 C.F.R. 556.113). This caused the food to be adulterated under section 402(a)(2)(C)(ii) of the FD&C Act.

The investigation also found that animals were held under insanitary conditions, likely leading to medicated animals with harmful drug residues entering the food supply, specifically due to a failure to maintain adequate treatment records. This constitutes adulteration under section 402(a)(4) of the FD&C Act.

Furthermore, the new animal drug Naxcel (ceftiofur sodium sterile powder, NADA (b)(4)) was adulterated. Caruso Cattle Company used Naxcel extralabelly on the bull without following the prescribed withdrawal period and without the supervision of