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U.S. Department of Health and Human Services

Animal & Veterinary

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Kansas Feed Mill Cited for GMP Violations

FDA Veterinarian Newsletter 2006 Volume XXI, No III

On August 16, 2006, the U.S. Attorney’s Office in the District of Kansas filed a Consent Decree of Permanent Injunction in the U.S. District Court for the District of Kansas against the feed manufacturer Cooperative Agricultural Services, Inc. (CO-AG), of Grinnell, KS, and CO-AG’s feed department manager, for multiple violations of current Good Manufacturing Practice (cGMP) requirements for medicated feed -production.

CO-AG produces medicated and non-medicated feed for consignees in Kansas, Oklahoma, and Colorado.

Inspectors went to the manufacturing facilities as part of an investigation into the death of several livestock that consumed feed from CO-AG. Inspectors at the CO-AG facilities documented many violations of the cGMP requirements for feed manufacturing, found under Title 21 Code of Federal Regulations, Part 225.

Under the terms of the Consent Decree, the defendants have agreed to stop manufacturing and distributing medicated animal feeds until they provide assurance to the satisfaction of Food and Drug Administration (FDA) officials that their medicated feeds are made in compliance with current cGMP 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.

Also 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 requires the defendants to have a qualified laboratory conduct analyses on their medicated feeds and they must take corrective action for all medicated feeds that the laboratory determines are outside the assay (potency) limits set by FDA regulation.

The Decree says that FDA can require a recall or shutdown in the event of future cGMP -violations.

FDA’s Kansas City District Office conducted the investigations that led to this Consent Decree. FDA’s Center for Veterinary Medicine, Division of Compliance, and FDA’s Office of the Chief Counsel worked with the U.S. Attorney’s Office in processing the case.