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.

The most recent FDA inspection of Baxter's Round Lake Facility, conducted on June 20-30, 2005, revealed deficiencies with the CGMP and QS requirements for devices, including the firm's failure to implement adequate management controls over its quality system operations and corrective and preventive actions (CAPA) procedures. During this inspection, design defects relating to the reliability of both the Colleague and the Syndeo Infusion Pumps were also revealed.


During the course of FDA's June inspection, Baxter initiated a voluntary world-wide hold on all Syndeo Infusion Pumps due to design defects that can cause the device to stop functioning. Also during the June inspection, Baxter initiated a voluntary world-wide hold on all Colleague Infusion Pumps due to a product design defect relating to a temperature sensitive component of the device's timing circuit, known as the Y2A crystal, which causes the timing circuit to fail.

Before the June 2005 inspection, FDA conducted two previous inspections of Baxter's medication delivery systems facility in Round Lake, Illinois, in September 2000 and June 2002, all of which revealed lack of management controls over the firm's quality system operations and inadequacy of its CAPA and complaint handling systems. These deficiencies undermined Baxter's ability to assure the quality of the devices manufactured at its Singapore plant. In September 1999, FDA issued a Warning Letter to the firm addressing its lack of CAPA procedures. In August 2001, another Warning Letter was issued to Baxter addressing deficiencies in its CAPA procedures.

The consent decree also resolves the disposition of Colleague and Syndeo Infusion Pumps that were seized by the Department of Justice on behalf of FDA in October 2005. The consent decree was entered today by the U.S. District Court for the Northern District of Illinois.

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