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June 29th: Baxter Healthcare Corp. Signs Consent Decree with FDA

Baxter Healthcare Corp. has signed a consent decree with FDA to stop making and distributing two brands of infusion pumps until manufacturing deficiencies are corrected. The models are the Colleague Volumetric Infusion Pump and the Syndeo Patient Controlled Analgesic Syringe Pump. Baxter was Non Compliant with FDA's current good manufacturing practice (CGMP) requirements and the Quality System (QS) regulation for devices.

The action stems from a June 2005 inspection that found inadequate management controls over quality system operations and CAPA procedures, as well as design defects. The management-controls issues had also been raised during inspections conducted in 2000 and 2002. During the 2005 inspection, Baxter placed a worldwide hold on both products after the design defects were discovered.

The decree requires Baxter to retain an independent expert consultant to conduct inspections of its infusion pump facilities and certify to FDA that corrections have been made. FDA will continue to monitor these activities through its inspections. Baxter is also required to submit to FDA an acceptable detailed corrective action plan to bring the Colleague and Syndeo Infusion Pumps currently in use in the United States into compliance with the Federal Food, Drug, and Cosmetic Act (the Act).

If corrective action under the decree is completed and Baxter has been allowed to resume manufacturing and distribution, the firm will hire an independent auditor to conduct audit inspections of its domestic infusion pump facilities at least once a year for at least four years. Results of these audit inspections will be reported directly to FDA. If Baxter fails to comply with any provision of the decree, or violates the Act or FDA regulations, FDA may order the firm to again stop manufacturing and distributing, recall the products or take other action.

CDRH has always been suspicious about the reliability of infusion pumps, and this incident will reinforce that. FDA's goal is to see that the necessary corrections are made, that the public health is protected and that users have access to safe and effective pumps.

For complete FDA report of this update, please refer to following links:
http://www.fda.gov/bbs/topics/NEWS/2006/NEW01402.html

If you have comments regarding this update, please email us at info@mdiconsultants.com

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