Invacare clear for re-inspection
By HME News Staff
Updated Fri April 28, 2017
ELYRIA, Ohio - Invacare has completed the final milestones required to lift a consent decree with the U.S. Food and Drug Administration, paving the way for a re-inspection, the company announced April 27.
“The re-inspection is an important step before the company may resume full operations at the impacted facilities,” Invacare stated in a press release.
The decree has limited Invacare's ability to manufacture and sell certain products from its corporate headquarters and Taylor Street facilities since December 2012.
Most recently, Invacare's third-party auditor submitted a third and final certification report confirming its compliance with specified FDA regulatory requirements. Invacare also submitted its own report substantiating its compliance. Both of these steps have now been completed.
“Since I arrived at Invacare in 2015, our No. 1 priority has been to build a culture of quality excellence,” stated Matthew Monaghan, chairman, president and CEO. “Our associates have embraced this, and we have made significant progress. We look forward to demonstrating this progress to FDA during its inspection.”
Invacare says it cannot predict the length or outcome of the re-inspection.
Earlier this month, the FDA notified Invacare that it had accepted an updated second certification report submitted by the company's auditor, allowing it to resume design activities at its corporate headquarters and Taylor Street facilities.
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