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October 25, 2012
06:37 EDTIVCInvacare continuing ot negotiate terms of FDA's consent decree of injuction
The injunction is related to the company's corporate and wheelchair manufacturing facilities in Elyria, Ohio. Simultaneously, the company continues to make significant progress on its quality systems remediation. Throughout the remediation, the company has engaged subject matter experts to assess the compliance of its new quality processes during the development and implementation stages to ensure they are in line with the FDA's Quality System Regulation. At this point, the company is confident that it will initiate its third-party expert certification audit in December, and the company expects it to be completed in the first quarter of 2013. The expert certification audit will be followed by an FDA re-inspection.
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