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BREAKING: Invacare satisfies consent decree requirements

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    Invacare president and CEO Matt Monaghan announces Tuesday at the company's facility on Taylor Street that conditions have been met for the federal consent decree.

    BRUCE BISHOP / CHRONICLE

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    Invacare President and CEO Matt Monaghan shows off a document that is no longer necessary after the company has satisfied a consent decree.

    BRUCE BISHOP / CHRONICLE

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    Dean Childers, senior vice president and general manager for North America, left, and President and CEO Matt Monaghan talk to workers outside of Invacare headquarters in Elyria on Tuesday.

    BRUCE BISHOP / CHRONICLE

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    John Mattes, associate director of engineering for Invacare, and CEO Matt Monaghan shake hands while showing off a power wheelchair Tuesday.

    BRUCE BISHOP / CHRONICLE

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    John Watkins, Matt Monaghan and Kimberly Wilhelm talk outside of Invacare headquarters in Elyria on Tuesday.

    BRUCE BISHOP / CHRONICLE

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ELYRIA  — Invacare Corporation says it has satisfied the requirements of its consent decree with the U.S. Food and Drug Administration, and can resume full operations at its Taylor Street manufacturing facility.

“(There’s) a lot of excitement starting this morning,” said Invacare Chairman and CEO Matt Monaghan, who noted that the company’s sales representatives are already telling customers about the news.

The company can now sell its equipment without a verification of medical necessity, and will undergo five years of audits by a third-party auditor selected by Invacare, who will inspect the facility every six months for the first year, and then annually for the next four years afterward.

The consent decree, which had been in effect since Dec. 21, 2012, stemmed from violations found during FDA inspections between 2002 and 2012, and called for Invacare to stop manufacturing, designing and distributing manual and powered wheelchairs and components at its Elyria facilities until it meets certain standards. The consent decree only affected the Elyria facility.

The last standards were met after an on-site inspection by the FDA that started May 30. In a letter dated July 24, the FDA said, “Invacare can design, manufacture, process, pack, repack, label, hold, distribute, import into or export from the United States of America, the subject devices at or from the Corporate or Taylor Street facilities.”

This is a developing story. Check back for updates.



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