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IVC > SEC Filings for IVC > Form 8-K on 16-Jul-2013All Recent SEC Filings

Show all filings for INVACARE CORP



Other Events, Financial Statements and Exhibits

Item 8.01. Other Events.
On July 16, 2013, Invacare Corporation (the "Company") announced that the United States Food and Drug Administration ("FDA") has found acceptable the Company's second third-party certification audit relating to design control systems at the Company's Corporate and Taylor Street facilities. This acceptance permits the Company to resume design activities for power wheelchairs and power beds. The remaining third-party certification audit is a comprehensive review of the Company's compliance with the FDA's Quality System Regulation at the impacted Elyria, Ohio facilities. The Company originally set an aggressive goal of completing this audit by June 30, but, in light of the scope and complexity of the audit, the Company is re-evaluating its expected timing of when the report will be completed and filed with the FDA. The Company is devoted to successfully completing this audit in a timely manner. After the certification report relating to this audit is submitted to the FDA, the agency will conduct its own inspection of the facility. Once the Company receives written notification from the FDA that the Corporate and Taylor Street facilities appear to be in compliance, the Company may resume full operations at those facilities. While the Company was pleased with the progress that it had made on the final third-party certification audit, the Company has identified a few areas in its quality system that require additional work. The Company needs to take the time now to reassess these sections of its quality system to ensure the processes it has put in place are sustainably compliant. The Company will complete these improvements with the same determination and commitment with which it achieved the first two audits.
The Company issued a press release relating to the announcement on July 16, 2013, a copy of which is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

Item 9.01. Financial Statements and Exhibits.
(d) Exhibits. Exhibit Number Description
99.1 Press Release, dated July 16, 2013.

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