Invacare Gets FDA Acceptance Of Second Certification Audit On Consent Decree

(RTTNews) - Invacare Corp. (IVC) announced that the United States Food and Drug Administration or 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.

The company said that the acceptance permits it to resume design activities for power wheelchairs and power beds.

Invacare said 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 facilities.

The company noted that it 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.

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.