Invacare Passes Second FDA Audit, Looks Ahead to Next Goal
- By Laurie Watanabe
- Jul 30, 2013
Invacare Corp., under a U.S. Food & Drug Administration (FDA) consent decree since late 2012 that has sharply curtailed its research, development and manufacturing activities, has passed the second of three third-party certification audits, and has set a new timetable for its next step.
On Dec. 20, the FDA announced the manufacturer's consent decree, stating in a news release, "Invacare Corp. and two of its top executives have signed a consent decree of permanent injunction requiring the company to stop manufacturing, designing, and distributing manual and powered wheelchairs and wheelchair components. Once the consent decree is entered into the court, Invacare will not be able to resume normal business operations at two of its Elyria, Ohio, facilities until it corrects all violations listed in the consent decree and it has been notified by the FDA that it is in compliance with the Federal Food, Drug, and Cosmetic Act."
In explaining the reason for the consent decree, the FDA said in that announcement, "Seven FDA inspections of the Invacare facilities subject to the consent decree since 2002 have documented violations of FDA's Quality System regulations, along with failures to properly report adverse events to the agency."
Invacare President/COO Gerald B. Blouch and Director of Product Risk & Quality Engineering Ronald J. Clines signed the consent decree, the FDA added.
Two Audits Down, One More to Go
On July 16, Invacare announced it had passed the second certification audit. The manufacturer had originally set an "aggressive" target date of June 30 for passing the third audit, but in the July 16 news release, Invacare said, "In light of the scope and complexity of the audit, the company is re-evaluating its expected timing of when the report will be completed and filed with the FDA."
Invacare announced in mid May that it had passed the first certification audit.
Lara Mahoney, Invacare's director of investor relations & corporate communications, said of the ongoing process, "The third audit is the most comprehensive of the three. It includes the entire quality system and the Taylor Street corporate facilities. When we receive or complete the third-party certification audit, they will write up their report and submit it to the FDA. We expect that to happen by mid November. Then the FDA will review that report."
Mahoney says Invacare expects the FDA to then conduct its own inspection. While an FDA inspection isn't absolutely mandated by the process, Mahoney says Invacare is anticipating one.
Meanwhile, passing the second certification audit "allowed us to get back into design controls, which is primarily engineering and new product development on power wheelchairs and power beds," Mahoney explained. "It's great news: It shows we're on the right track and doing the right things, but admittedly while we'll be able to have some of our engineers now focus on new product development again, we're still going to keep a lot of them focused on making sure we successfully complete the third certification audit. That is our number-one priority."
As far as when the FDA would be expected to conduct its final inspection following the third certification audit, Mahoney declined to make an estimate.
"It's in their hands," she said. "They take the time they need to go through the process."
Laurie Watanabe is the editor of Mobility Management. She can be reached at email@example.com.