Invacare Corp. (invacare.com) has announced it “intends to enter into discussions” with the U.S. Food & Drug Administration (FDA) regarding a consent decree that could cause the mobility and DME manufacturer to temporarily suspend some operations at its Elyria, Ohio, location.
In a news announcement dated Dec. 8, Invacare said, “The FDA has proposed a consent decree that would require suspension of certain operations at the facilities until they are determined by the FDA to be in compliance.”
Invacare added that the consent decree of injunction relates “to previously disclosed inspectional observations at the company’s corporate facility and its wheelchair manufacturing facility in Elyria, Ohio.” The news release said, “Invacare is committed to full compliance with FDA regulations, and it intends to work cooperatively with the FDA to resolve the agency’s concerns.”
The Wall Street Journal reported that Invacare stock fell 28.57 percent, closing at $14.70 on Dec. 8, following the news.
A story published by The Chronicle Telegram, a publication based in Elyria, quoted Invacare spokesperson Lara Mahoney as calling the possibility of a production suspension “highly likely,” though the suspension probably wouldn’t come for several months.
