ELYRIA — Production at Invacare Corp.’s Taylor Street plant, where about 500 people manufacture motorized wheelchairs and other products, could be temporarily suspended as a result of a proposed consent agreement with the federal government over quality-control monitoring issues, a company spokeswoman said.
“It’s highly likely there will be some suspension of production, and we’ll do our best to minimize the impact on our associates and customers,” Invacare spokeswoman Lara Mahoney said.
It is unknown when production might be suspended, but any disruption in production would probably not take place for several months, she said.
The company announced Thursday that the FDA wants to enter into a consent decree with Invacare to ensure that the company becomes compliant with its quality system regulations as quickly as possible.
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, she said.
Mahoney said it is unknown when production might stop until negotiations take place between Invacare and the FDA regarding the consent agreement.
“We’re going to be in full production until we finalize terms of the consent decree,” Mahoney said. “At that point, we’ll know the details of the agreement and the terms of the suspension of production.”
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, according to Mahoney.
The FDA may take additional actions if the company does not resolve issues dealing with those observations, she said.
A representative of the FDA reached Thursday evening referred comment to an agency spokesman who was unavailable.
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 the issue involving the Florida plant is separate from those involving the Taylor Street plant and its headquarters.
Mahoney said Invacare issued a recall for the beds and provided new electric cords so there was no possibility the beds could be plugged in incorrectly.
She said none of the issues involving the Elyria plant or headquarters concerned malfunctioning products.
“There is no product safety problem,” Mahoney said. “We have millions of people using our products, so quality is very important to us but we need to work with the FDA, so our quality assurance system is comprehensive.”
Meanwhile, the Bloomberg news service reported that Invacare’s stock sank 29 percent at the close of trading Thursday, the biggest single-day decline since Dec. 27, 1984.
RTTNews reported on April 4, that Invacare announced the appointment of Colleen Craven, who had served as vice president of corporate compliance and business practices at Endo Pharmaceuticals, as Invacare’s chief compliance officer, but she resigned for personal reasons 18 days later.
Mahoney said an interim compliance officer has been serving since then, and the company is seeking a permanent replacement.
In addition, over the past year, she said Invacare added resources to its regulatory affairs and quality systems departments, and hired outside experts with proven quality systems and regulatory experience in the medical device industry to accelerate its improvement process.
Gerald B. Blouch, Invacare CEO and president since Jan. 1, is overseeing the process, Mahoney said.
“While we are disappointed that the agency proposed a consent decree, we respect the FDA’s important regulatory role, and we look forward to working with the agency to fully meet its expectations,” Mahoney said.
Invacare has about 6,100 employees around the world, including about 1,300 in Northeast Ohio facilities in Elyria, North Ridgeville and Akron, according to Mahoney.
In October, Invacare announced it was laying off 50 employees, including about 30 at its Elyria headquarters.
Before that, its 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.
In 2005, the medical device manufacturer shed approximately 230 local jobs when it shifted some production to a factory in China.
Invacare is the city’s No. 1 manufacturing employer, City Auditor Ted Pileski said last month while discussing a 4.8 percent increase in income tax collection in 2011 compared with 2010.
Contact Cindy Leise at 329-7245 or firstname.lastname@example.org.