April 30, 2008 - Physio-Control Inc. has reached an agreement on a consent decree with the FDA regarding its quality system improvements for its external defibrillator products, which outlines steps the company must take to regain permission for unrestricted distribution of its external defibrillators.
The agreement was filed on Friday, April 25, in the U.S. District Court for the Western District of Washington and is subject to that court's approval. The agreement addresses issues raised by the FDA during inspections regarding the company's quality system processes and outlines the actions Physio-Control must take in order to resume unrestricted distribution of its external defibrillators.
"During the last year, we've made significant investments and improvements to our quality systems and we are pleased to have a plan that formalizes the path to resume full distribution," said Brian Webster, president of Physio-Control. "We have the right people in the organization to execute to the plan and we are working with the FDA to expedite resumption of full operations."
In the meantime, worldwide shipments to meet critical customer requirements and certain specified public health needs will continue.
For more information: www.physio-control.com