FDA WARNING_LETTER - Cheshire Valley Farms LLC - June 13, 2013

An FDA inspection of Cheshire Valley Farms LLC in Oxford, New York, conducted on June 4, 7, and 13, 2013, revealed significant violations of the Federal Food, Drug, and Cosmetic Act. The primary finding was that the farm offered an adulterated bob veal calf for slaughter on January 2, 2013. Tissue analysis by USDA/FSIS identified desfuroylcentiofur (a marker for ceftiofur) at 1.46 parts per million (ppm) in muscle and 8.6 ppm in kidney, significantly exceeding FDA tolerances of 1.0 ppm for muscle and 0.4 ppm for kidney, as codified in 21 C.F.R. 556.113(b)(3). This constitutes adulteration under section 402(a)(2)(C)(ii) of the FD&C Act. Furthermore, the investigation found that the farm holds animals under inadequate conditions, increasing the likelihood of medicated animals bearing harmful drug residues entering the food supply. This includes a failure to maintain treatment records and segregate treated animals, rendering food from such animals adulterated under section 402(a)(4) of the FD&C Act. Cheshire Valley Farms is required to take prompt corrective action and submit a written response to the FDA within fifteen working days. The response must detail steps taken to correct violations, prevent recurrence, and provide documentation. Failure to comply may lead to further regulatory actions, including seizure or injunction.