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Invacare Corp Receives FDA Acceptance Of Second Certification Audit Related To Consent Decree

Tuesday, 16 Jul 2013 09:19am EDT 

Invacare Corp 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 System Regulation at the impacted Elyria 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. 

Company Quote

0.08 +0.62%
10:54am EDT