Baxter signs consent decree with FDA
The FDA announced that Baxter Healthcare Corp. and two of its top corporate executives have signed a consent decree of condemnation and permanent injunction for certain infusion pumps made by the firm. They agreed to stop manufacturing and distributing within the United States all models of the Colleague Volumetric Infusion Pump (Colleague) and the Syndeo Patient Controlled Analgesic Syringe Pump (Syndeo) until they correct manufacturing deficiencies and until the devices are made in compliance with the FDA's current good manufacturing practice (CGMP) requirements and the Quality System (QS) regulation for devices.
Baxter signs consent decree with FDA
The FDA announced that Baxter Healthcare Corp. and two of its top corporate executives have signed a consent decree of condemnation and permanent injunction for certain infusion pumps made by the firm. They agreed to stop manufacturing and distributing within the United States all models of the Colleague Volumetric Infusion Pump (Colleague) and the Syndeo Patient Controlled Analgesic Syringe Pump (Syndeo) until they correct manufacturing deficiencies and until the devices are made in compliance with the FDA's current good manufacturing practice (CGMP) requirements and the Quality System (QS) regulation for devices. Under the terms of the consent decree, signed by Baxter's chairman, CEO, and other top executives, the company has agreed to take necessary measures to ensure compliance with the CGMP and QS requirements by all of its facilities that manufacture, process, pack, label, hold, or distribute the Colleague and Syndeo Pumps. The decree also requires Baxter to retain an independent expert consultant to conduct inspections of its infusion pump facilities and certify to the FDA that corrections have been made. The agency will continue to monitor these activities through its inspections.
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