ELYRIA — Invacare Corp. plans a third-party audit of its efforts to comply with quality control regulations of the Food and Drug Administration, a company spokeswoman said Friday.
The third-party audit will take place in the fourth quarter of this year as Invacare’s attorneys continue to negotiate terms of a proposed consent agreement with the FDA, said Invacare spokeswoman Lora Mahoney.
“We want to make sure we’re addressing the FDA’s observations,” Mahoney said.
So far, Invacare, Elyria’s biggest manufacturer, has staved off a threatened shutdown of its Taylor Street plant after the FDA issued a proposed consent decree last December.
While negotiations take place, operations continue as usual, Mahoney said. There are approximately 1,200 employees on the campus that straddles the Elyria/North Ridgeville border.
Mahoney said the company has hired additional quality control experts after it announced in October that it was laying off 50 employees, including about 30 at its Elyria headquarters.
She declined to discuss how many new quality-control experts were hired, except to say, “It’s in the double digits and a significant effort to rebuild our quality system.”
In late December, the company brought in Doug Uelmen to serve as vice president in charge of quality control. Uelmen has held similar roles at other companies, including those that make medical devices.
The FDA regulates how medical device companies track and report their quality assurance efforts. The agency routinely inspects manufacturing facilities and issues observations if it determines regulations are not being met.
Meanwhile, FDA spokeswoman Sarah Clark-Lynn declined to comment, saying the agency does not comment on ongoing issues.
Mahoney said the third-party audit is designed to ensure “we’re addressing the FDA’s observations.”
Last December, the company announced that production at its Taylor Street plant, where about 500 people manufacture motorized wheelchairs and other products, could be temporarily suspended as a result of the proposed consent agreement with the federal government.
Mahoney said at that time it was “highly likely there will be some suspension of production, and we’ll do our best to minimize the impact on our associates and customers.”
Within the FDA’s proposed consent decree, there are provisions that would require suspension of certain operations and functions at the Taylor Street plant and company headquarters until they are certified to be in compliance with FDA regulations, Mahoney said at the time.
Mahoney said Friday Invacare will not know details of the agreement or terms of any suspension of production until the consent decree is finalized.
“We’re controlling what we can control,” she said. “We’re not saying there won’t be a suspension, but at the same time we’re pleased we have the time to make sure we get things right.”
On Dec. 15, 2010, the FDA issued a warning letter to Invacare that referred to incidents involving Invacare electronic beds manufactured in Sanford, Fla., that caught fire.
The letter stated the company’s response was not adequate, and it may indicate “serious problems in your firm’s manufacturing and quality assurance systems.”
Mahoney said previously none of the issues involving the Elyria plant or headquarters concerned malfunctioning products.
She said the issue involving the Florida plant was separate from those involving the Taylor Street plant and its headquarters.
While the consent decree involves the Taylor Street plant and the Elyria headquarters, improvement efforts will be company-wide, she said.
“It’s more than a plant — it’s a quality system transformation,” Mahoney said. “It covers everything from how a customer service department collects and tracks customer quality data information to how equipment is validated — which means making sure a piece of equipment is going to do what it’s supposed to do and document it.”
Invacare announced in January it was moving production of its Solara manual wheelchairs from Elyria to a facility operated by the company in Reynosa, Mexico.
It didn’t cost any of the company’s local employees their jobs. The company said at that time that moving production of the Solara line was part of its long-term manufacturing strategy, but Invacare made the change earlier than anticipated so it could focus on concerns raised by the FDA.
Prior to the 30 layoffs in Elyria last October, the last major round of layoffs was in 2006, Mahoney said, and cost around 200 workers their jobs. But she said those were voluntary layoffs with severance packages and retraining.
Contact Cindy Leise at 329-7245 or cleise@chroniclet.com.
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