FDA WARNING_LETTER - Maxwell Farms, LLC - June 19, 2015

On June 9 and 19, 2015, the FDA inspected Maxwell Farms, LLC, a dairy farm in Cambridge, New York. The inspection revealed violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Specifically, on January 26, 2015, Maxwell Farms sold a bob veal calf for slaughter. USDA/FSIS analysis of tissue samples from this animal, slaughtered on January 27, 2015, found desfuroylceftiofur (a marker for ceftiofur) at 2.4 ppm in kidney tissue. This level exceeds the FDA tolerance of 0.4 ppm for desfuroylceftiofur in cattle kidney tissue, as per 21 C.F.R. 556.113(b)(3)(i). This constitutes adulteration under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. § 342(a)(2)(C)(ii), as the food contained an unsafe new animal drug.

Additionally, the investigation found that animals were held under insanitary conditions, specifically due to a failure to maintain complete treatment records. This practice increases the likelihood of medicated animals with harmful drug residues entering the food supply, rendering the food adulterated under section 402(a)(4) of