The home healthcare supplies maker said the FDA "found acceptable" its 1st certification audit of qualification and validation documentation for equipment and processes at the Taylor St. plant in Elyria, Invacare’s home base. That means the facility can begin shipping product to other Invacare facilities for further manufacturing or service, according to a press release.
Last year Invacare agreed to a consent decree with the FDA that temporarily shut down 2 facilities and forced the sale of its Invacare Supplies Group division to AssuraMed for $151 million and led to layoffs for more than 140 workers, or about 40% of its total workforce.
Resuming limited operations at the Taylor St. plant is a step toward having the facility back online 100%, president & CEO Gerald Blouch said in prepared remarks.
”This is an important step forward for the company in demonstrating its quality systems compliance to the FDA,” Blouch said. ”I am incredibly proud of the Invacare team and all of the work that they have put into improving our quality systems. This is the first critical step in resuming full production at the Taylor Street manufacturing facility.”
Invacare must still pass 2 other audits. The 1st, of its design control systems, is under review by the FDA, according to the release. Clearing that hurdle will enable Invacare’s R&D department to return to product development.
The final audit, a comprehensive review of Invacare’s compliance with the FDA’s Quality System Regulation, is "well underway," the company said.
"After the certification report relating to that audit is submitted to the FDA, the agency will conduct its own inspection of the facility. Once the company receives written notification from the FDA that the corporate and Taylor Street facilities appear to be in compliance, the company may resume full operations at those facilities," according to the press release.
IVC shares were up 8.1% to $14.76 apiece as of about 2:40 p.m. today.