Update: Third-party auditor delays Invacare’s progress

Company expects re-audit in February
Thursday, December 26, 2013

ELYRIA, Ohio – Invacare has more work to do before it submits a final audit to the U.S. Food and Drug Administration (FDA) for approval.

Invacare announced Dec. 23 that a third-party auditor informed the company on Dec. 20 that it must make improvements in clearing a backlog in its updated complaint handling system before moving forward.

“While we are disappointed that the final certification report is not ready to filed, we have made significant progress in our quality systems improvements over the past two years,” stated President and CEO Gerry Blouch in a press release. “We remain fully committed to meeting expectations of our third-party auditor and, ultimately, the FDA.”

Invacare had planned to submit the audit to the FDA first in June and then in November. Now the company doesn’t expect the third-party auditor to return to re-audit the system until February.

A big reason for the backlog: The updated system funnels all sources of data through one system, putting a strain on Invacare’s ability to investigate complaints, according to the release.

“The company has added additional contractors to further expedite clearing the backlog to achieve and demonstrate sustainable improvement,” the release states.

Invacare must submit the audit and get it approved by the FDA to resume full operations at its corporate and Taylor Street manufacturing facilities. Two previous audits cleared the way for the company to resume 1.) manufacturing and distributing parts, components, accessories and subassemblies; and 2.) design activities.

After a final audit is submitted and approved, the FDA will inspect the facilities. A consent decree with the FDA has limited operations there since December of 2012.

Invacare will provide an update on its progress in its year-end earnings release.