Invacare clears first FDA hurdle

Tuesday, May 14, 2013

ELYRIA, Ohio – Invacare announced May 13 that the Food and Drug Administration (FDA) has approved the first of three audits, allowing the company to resume certain production at its Taylor Street facility.

Invacare may now resume manufacturing and distributing parts, components, accessories and subassemblies for further manufacturing at other facilities, according to a press release.

“This is the first critical step in resuming full production at the Taylor Street manufacturing facility,” stated President and CEO Gerry Blouch, in the release.

As part of a consent decree hammered out with the FDA late last year, Invacare agreed to limit production at its Taylor Street facility.

Invacare is still waiting to hear back from the FDA about the second audit submitted for approval, which would allow the company to resume design activities. Once the FDA approves that audit, it will be able to “refocus its engineering resources on new product development,” according to the release.

The third and final audit—a comprehensive review of the company’s compliance with the FDA’s Quality System Regulation—is “well underway,” the released noted. Once that audit is submitted and approved, the FDA will conduct its own audit.

“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,” the release stated.

On Tuesday morning, in the wake of the announcement, Invacare’s stock was up 7.96% to $14.75 per share.

The company’s consent decree with the FDA has wreaked havoc on its North American/HME segment. For the first quarter of 2013, net sales decreased 13.6% to $152.2 million.