FDA escalates pressure on Invacare
ELYRIA, Ohio – Invacare announced this week that the U.S. Food and Drug Administration (FDA) has proposed a consent decree of injunction that would require it to suspend certain operations at two facilities.
Invacare intends to enter into discussions with the FDA regarding the terms of the consent decree, it stated in a press release.
“Invacare is committed to full compliance with FDA regulations, and it intends to work cooperatively with the FDA to resolve the agency’s concerns,” the company stated.
The decree is based on observations at Invacare’s corporate facility and its wheelchair manufacturing facility, both in Elyria.
Invacare stated in the release that, over the past year, it has made systemic improvements in its FDA compliance process. It has also added internal resources and engaged outside experts with proven medical device regulatory experience to accelerate these improvements.
Earlier this year, Invacare received a warning letter from the FDA regarding its bed manufacturing facility in Sanford, Fla. The agency charged, among other things, that the manufacturer failed to correctly document allegations that some of its hospital beds malfunctioned.
Read Monday's HME Newswire for an interview with Invacare President and CEO Gerald Blouch.