Invacare (NYSE:IVC) is allowed to resume design activities at HQ and a Taylor Street facility in Elyria, Ohio, after the FDA gave the company a partial go-ahead following a manufacturing shut-down last year.
Following a 3rd-party audit of Invacare’s facilities, the FDA puts its stamp of approval on the certification reports, putting the company one step closer to exiting the injunction phase of a consent decree issued last year.
Invacare is slated to ramp up its wheelchair and power bed design operations at these 2 facilities. The company said it will later this month update investors on the final pending certification report, which includes an exhaustive 3rd-party audit of all FDA quality compliance issues at impacted buildings in Elyria, Ohio.
"While we were pleased with the progress that we had made on the final 3rd-party certification audit, we have identified a few areas in our quality system that require additional work," said CEO Gerald Blouch in prepared remarks. "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 2 audits."
The FDA shut down operations in Elyria last year with a consent decree that forced the company to sell its Invacare Supplies Group division to AssuraMed for $151 million and layoff 40% of its workforce.
Invacare saw a bit of good news in May, when the FDA permitted limited manufacturing activities after the 1st of 3 audits came up clean.