Invacare Makes Headway on Consent Decree
Manufacturer completes final two steps needed to allow FDA to inspect facilities; length of inspection process or ensuing work remains unknown.
- By David Kopf
- Apr 27, 2017
HME manufacturer Invacare Corp. reports it has completed the final two steps required for the Food and Drug Administration to re-inspect manufacturing facilities that have been stalled since being affected by an FDA consent decree.
The company’s Corporate and Taylor Street facilities have been under the consent decree since December 2012. The re-inspection is the next step required before those facilities can start working toward resumption of full operations, and should commence within 30 days, based on the terms of the consent decree. What is unknown is how long the re-inspection process will last, or how much additional work will ensure in the process.
To get to the re-inspection stage, the FDA had to receive a third-party expert certification report confirming Invacare’s substantial compliance with specified FDA regulatory requirements, as well as the company's own report, as required under paragraph 5(H) of the consent decree, substantiating its compliance. The company reported that both of these steps have now been completed.
''Since I arrived at Invacare in 2015, our number one priority has been to build a culture of quality excellence,” said Matthew Monaghan, chairman, president and CEO of Invacare. ”Our associates have embraced this, and we have made significant progress. We look forward to demonstrating this progress to FDA during its inspection.''
David Kopf is the Editor of HME Business.