FDA WARNING_LETTER - Glenville Farms - July 03, 2014

On July 2-3, 2014, the FDA inspected Glenville Farms, identifying violations of the Federal Food, Drug, and Cosmetic Act. The farm sold a dairy cow for slaughter on December 16, 2013, which USDA/FSIS analysis found to contain desfuroylceftiofur (ceftiofur marker residue) at 0.83 ppm 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.

Additionally, the investigation revealed insanitary conditions, specifically the failure to identify and segregate treated animals, making it likely that medicated animals with harmful drug residues could enter the food supply. This constitutes adulteration under section 402(a)(4) of the FD&C Act. Glenville Farms is responsible for ensuring overall compliance. The FDA requires prompt corrective action and procedures to prevent recurrence within fifteen working days of receiving the letter. Failure to comply may result in regulatory actions like seizure or injunction. A written response detailing corrective steps and timelines must be submitted to the FDA Philadelphia District Office.