ELYRIA, Ohio--(BUSINESS WIRE)--Invacare Corporation (NYSE:IVC) today announced that, while it has made significant progress on the final third-party expert certification audit relating to the quality systems at its corporate and Taylor Street manufacturing facilities in Elyria, Ohio, it has recently received additional input from the third-party expert. This input has clarified that some additional work is required in a few particular areas before the final certification report can be provided to the United States Food and Drug Administration (FDA). The final third-party certification audit is a comprehensive review of the Company’s compliance with the FDA’s Quality System Regulation (QSR) at the impacted Elyria facilities. The Company has already completed two third-party expert certification audits, and the FDA has found the results of both to be acceptable. In the first two audits, the third-party expert certified that the Company’s equipment and process validation procedures and its design control systems were compliant with the FDA’s QSR.
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