FDA WARNING_LETTER - Culpeper Farmers' Cooperative, Inc. - February 11, 2011

An FDA inspection of Culpeper Farmers' Cooperative, Inc., dba CFC Farm Home Center, a licensed medicated feed mill, from January 25 to February 11, 2011, revealed significant deviations from Current Good Manufacturing Practice (CGMP) for Medicated Feeds (21 C.F.R. Part 225). These deviations render medicated feeds adulterated under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act), and non-medicated feeds adulterated under section 402(a)(4) due to insanitary conditions.

Violations included: * **Facility Maintenance (21 C.F.R. 225.20(b)):** The feed mill and warehouses were not clean or orderly, with spilled feed, broken bags, and trash providing food and harborage for rodents. A mouse infestation and numerous rodent excreta pellets were found throughout the facility, which also had disrepair allowing rodent access. * **Drug Component Control (21 C.F.R. 225.42):** Drug components were not properly controlled; rodent excreta pellets were found inside a bag of Deccox 6% (a Category I Type A medicated article). * **Drug Component Records (21 C.F.R. 225.42