Invacare clears second hurdle
ELYRIA, Ohio – Invacare announced July 16 that the U.S. Food and Drug Administration (FDA) has approved the second of three audits, allowing the company to resume design activities for power wheelchairs and electric beds at its corporate and Taylor Street facilities.
“This acceptance permits us to resume design activities on the critical new product development projects that will help us regain our market share when we exit the injunctive phase of the consent decree,” stated President and CEO Gerald Blouch.
The FDA approved the first of Invacare’s three audits in May, allowing the company to resume manufacturing and distributing parts, components, accessories and subassemblies at the Taylor Street facility for further manufacturing at other facilities.
Up next: Invacare will complete and submit for approval a third and final audit reviewing its overall compliance with the FDA’s Quality System Regulation. The company had set an “aggressive goal” of completing this audit by June 30, but it’s still a work in progress.
''While we were pleased with the progress that we had made on the final third-party certification audit, we have identified a few areas in our quality system that require additional work,” Blouch stated. “We need to take the time now to reassess these sections of our quality system to ensure the processes we have put in place are sustainably compliant. Be assured that we will complete these improvements with the same determination and commitment with which we achieved the first two audits.”
Invacare will provide an update on its progress on the third audit in an earnings release scheduled for July 25.
After the FDA receives and reviews the third audit, it will conduct its own review. Once Invacare receives written notification from the agency that the corporate and Taylor Street facilities appear to be in compliance, the company may resume full operations at those facilities.
Invacare announced in late 2012 that it had reached an agreement with the FDA that would limit production and certain design activities at the corporate and Taylor Street facilities until they were inspected and found in compliance with regulations through a third-party review.