The two top executives of Physio-Control and its parent company Medtronic have signed a consent decree of permanent injunction related to automatic external defibrillators (AEDs) manufactured by Physio-Control.
The agency said that the consent decree prohibits the manufacture, distribution and export of specified AEDs at or from Physio-Control’s facility in Redmond, Wash., until the devices and facilities have been shown to be in compliance with the FDA’s current Good Manufacturing Practice requirements (cGMP), as set forth in the Quality System regulation for devices.
The FDA said its inspections conducted in October 2006 and January 2008 revealed cGMP deficiencies, including failure to establish and maintain adequate procedures for validating the device design, and failure to establish and maintain adequate procedures for implementing corrective and preventive actions. The deficiencies do not necessarily mean that the defibrillators currently on the market will harm patients, but the FDA said it is requiring corrections to ensure the continued availability of safe, effective and reliable products.
The agency also noted that previous regulatory inspections in 2000, 2003 and 2005 showed similar violations. The FDA issued warning letters after the 2000 and 2005 inspections, citing the cGMP violations.
Under terms of the decree, Physio-Control and Medtronic agreed to take the necessary measures to ensure that AEDs manufactured and designed at the Redmond facility comply with cGMP requirements and FDA regulations for reporting device corrections and removals.
The FDA said that manufacturing and distribution may resume once it is satisfied that the Redmond facility is in compliance with the law. To ensure compliance, an outside expert will conduct yearly audit inspections for five years and submit findings to the agency.
The decree also stipulated that the companies are subject to liquidated damages in the amount of $15,000 per day if they fail to comply with any of the provisions of the decree, and an additional sum of $15,000 for each violation of the consent decree, the Federal Food, Drug and Cosmetic Act, or FDA regulations.
The decree, filed April 25 in the U.S. District Court for the Western District of Washington, is subject to court approval.
“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,” Brian Webster, president of Physio-Control, said in a statement. “We have the right people in the organization to execute the plan and we are working with the FDA to expedite resumption of full operations.”