August 31, 2006
Consent Decree Filed In Medicated Feed Case Filed Against Cooperative Agricultural Services, Inc.
On August 16, 2006, a Consent Decree of Permanent Injunction was filed in the U.S. District Court for the District of Kansas against Cooperative Agricultural Services, Inc. (CO-AG) and CO-AG's Feed Department Manager (the defendants) of Grinnell, Kansas. The firm produces medicated and non-medicated feed for consignees in Kansas, Oklahoma and Colorado. The injunction is based on multiple consecutive inspections where significant violations of FDA’s Good Manufacturing Practice (GMP) requirements for feed manufacturers, Title 21 Code of Federal Regulations, Part 225, were documented. The impetus for these investigations was the death of livestock where suspect CO-AG feed was fed to the animals.
Under the terms of the Consent Decree, the defendants agreed to stop manufacturing and distributing medicated animal feeds until they provide assurance, to FDA's satisfaction, that their medicated feeds are made in compliance with current GMP requirements, in accordance with label specifications, and in a manner ensuring that all uses of new animal drugs conform to each drug's approved application. Under the Decree, the defendants are required to retain an expert consultant to conduct inspections of their manufacturing facility and certify to FDA that corrections have been made. FDA will continue to monitor these activities. The Decree also requires the defendants to have a qualified laboratory conduct analyses on their medicated feeds and to take corrective action for all medicated feeds that the laboratory determines are outside the assay (potency) limits set by FDA regulation. Further, the Decree provides for FDA to require a recall or shutdown in the event of future violations.
FDA's Kansas City District Office conducted the investigations that lead to this Consent Decree. FDA's Center for Veterinary Medicine Division of Compliance and FDA’s Office of the Chief Counsel, and the U.S. Attorney's Office in the District of Kansas were responsible for processing and filing the case.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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