ELYRIA — Invacare Corporation says it has satisfied the requirements of its consent decree with the U.S. Food and Drug Administration, and can resume full operations at its Taylor Street manufacturing facility.
“(There’s) a lot of excitement starting this morning,” said Invacare Chairman and CEO Matt Monaghan, who noted that the company’s sales representatives are already telling customers about the news.
The company can now sell its equipment without a verification of medical necessity, and will undergo five years of audits by a third-party auditor selected by Invacare, who will inspect the facility every six months for the first year, and then annually for the next four years afterward.
The consent decree, which had been in effect since Dec. 21, 2012, stemmed from violations found during FDA inspections between 2002 and 2012, and called for Invacare to stop manufacturing, designing and distributing manual and powered wheelchairs and components at its Elyria facilities until it meets certain standards. The consent decree only affected the Elyria facility.
The last standards were met after an on-site inspection by the FDA that started May 30. In a letter dated July 24, the FDA said, “Invacare can design, manufacture, process, pack, repack, label, hold, distribute, import into or export from the United States of America, the subject devices at or from the Corporate or Taylor Street facilities.”
This is a developing story. Check back for updates.
- Invacare back at full production
- Invacare seeks new employees
- Invacare to cut 110 jobs
- 50 employees laid off at Invacare, most at company headquarters
- One decree left for Invacare to fulfill
- Invacare sells properties in leaseback deal
- Invacare names new CEO
- Invacare making progress in FDA review of Elyria facility
- Invacare will get audit in response to FDA decree