FDA gives Invacare permission to ramp up manufacturing

Invacare is finally free to build as many wheelchairs as it pleases.

The U.S. Food and Drug Administration has given the company permission to ramp up manufacturing at its Taylor Street plant in Elyria.

The decision could help the medical equipment maker reverse its fortunes: In December 2012, the FDA issued a consent decree forcing the company to shut down almost all manufacturing operations at its Taylor Street plant and overhaul its quality control system.

Invacare has lost money every year since then.

But the company's stock price jumped almost immediately after Invacare put out a news release announcing the FDA's decision. That price was hovering around $15 per share at 10:30 a.m. on Tuesday, July 25, up about 19% from $12.65 when markets closed on July 24.

The FDA hasn't lifted the entire consent decree, however: Invacare's headquarters and Taylor Street plant will still have to undergo regular inspections over the next five years to ensure that the company remains in compliance with FDA standards, according to the news release. A third-party auditor will conduct inspections every six months for the first year and then every 12 months for the next four years. Invacare will chose the auditor.

Invacare CEO Matthew Monaghan said that the ordeal has made the company stronger.

"The consent decree was a precipitating event for Invacare, and it caused us to evaluate all areas of the business," he stated in the release.

"We are emerging from this experience with a new, stronger foundation. While our transformation remains ongoing, we now have a leadership team with robust medical device and quality backgrounds; a clear transformation strategy that aligns the company toward its more clinically complex mix of products; a new commercial focus on our clinical competencies to better meet the needs of our complex rehab and post-acute customers; and an exciting new product portfolio," Monaghan said.

"FDA gives Invacare permission to ramp up manufacturing in Elyria" originally appeared in Crain's Cleveland Business.