The U.S. Food and Drug Administration has asked home health products maker Invacare (NYSE:IVC) to enter into a legal agreement that would require the company to suspend “certain” wheelchair manufacturing operations.
Under the terms of the FDA’s proposal, Invacare would be required to suspend those operations at its Elyria, Ohio factory until the agency determines that the company is in compliance with FDA regulations, according to a statement from Invacare.
However, Invacare hasn’t agreed to the FDA’s proposal. In a phone interview, CEO Gerry Blouch said the company is in negotiations with the FDA over the terms of the agreement, which is referred to as a “consent decree of injunction.”
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Blouch said the FDA’s proposal “was not precise enough” for him to provide specifics on exactly what manufacturing operations the agency is asking it to suspend.
Due to what Blouch perceives as that lack of precision, he said he was unable to characterize the impact to Invacare’s business of a suspension of manufacturing operations such as what the FDA is seeking from the company.
An FDA spokeswoman didn’t return a call.
The specific regulations that the FDA said Invacare wasn’t in compliance with “relate generally to processes” involved in the manufacture of wheelchairs, Blouch said.
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Invacare said it is committed to full compliance with FDA regulations and intends to work cooperatively with the agency to resolve its concerns, according to the statement.
About a year ago, Invacare received a warning letter from the FDA that contained unsubstantiated reports of fires, entrapments and deaths caused by the company’s adjustable electric beds. The company hired a chief compliance officer earlier this year.
