Cheshire Valley Farms LLC – FDA Warning Letter, Jun 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.
ID · 17f1a5cd-6764-490e-a148-e638e091eb78
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.