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Invacare satisfies FDA order, can reopen plant

July 25, 2017

 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.”

http://bit.ly/2ux5QOa

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