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FDA accepts Invacare’s first certification audit related to consent decree

The United States Food and Drug Administration (FDA) has accepted Invacare's first certification audit relating to the qualification and validation documentation for equipment and processes at the Taylor Street manufacturing facility in Ohio, US.

The acceptance allows the company’s Taylor Street facility, which currently subject to limitations on production due to an FDA consent decree, to resume manufacturing and distributing parts, components, accessories and subassemblies to Invacare facilities other than the Taylor Street or Corporate facilities for further manufacturing or to provide service related to medical devices manufactured at those other Invacare facilities.

Invacare Corporation president and CEO Gerald Blouch said, "This is the first critical step in resuming full production at the Taylor Street manufacturing facility."

The second audit is related to the company’s design control systems and is currently being reviewed by the FDA.

After receiving the FDA approval for the second certification report, the company may resume design activities that enable to refocus on its engineering resources for new product development.

The third-party certification audit is a comprehensive review of the company’s compliance with the FDA’s Quality System Regulation at the impacted Elyria facilities.

After the submission of the certification report to the FDA, the agency will conduct its own inspection of the facility.