The QMN Weekly Bulletin
Medical Devices / Regulatory Affairs / Inspections and Audits

Invacare Focusing on Complaints to Wrap Up Consent Decree

Jan. 10, 2014

Invacare says it has made “significant progress” on its FDA consent decree, but must do some additional work on its complaint system before an independent auditor provides final certification to the agency.

The company is working on an action plan to address observations from the auditor’s third audit and has added some contractors to help whittle down a complaint backlog, Investor Relations Director Lara Mahoney said. The third-party contractor will revisit Invacare in February, and the devicemaker hopes to have an estimate of the remaining backlog time soon after that. “Every day we’re working through it,” Mahoney said.

The first two audits required by the decree covered equipment, process validation procedures and design control systems at the company’s Taylor Street and Elyria, Ohio, manufacturing facilities. The FDA deemed the results of those audits to be acceptable.

Invacare was placed under the consent decree in December 2012, agreeing to stop making and distributing manual and power wheelchairs until multiple good manufacturing process violations are corrected.

The company has since overhauled its complaint handling system and now requires all complaint data to flow through one system, which led to the backlog. Recently, Invacare disclosed that it has been closing significantly more complaints than are opened under the new system, which was launched several months ago, and Mahoney acknowledged that complaint data are temporarily coming in faster than the company can train new employees to investigate the reports. The additional contractors will help the company catch up, he said.

Once the auditor’s final certification report and Invacare’s compliance report are submitted, the FDA will inspect the corporate and Taylor Street facilities. Pending a successful inspection outcome, the agency will provide written notification that Invacare can resume full operations.

Invacare said it doesn’t have an estimated time for completing the final certification report, but will update investors on its progress in an early February earnings release.

Earlier this year, Invacare laid off 143 employees as a result of the decree and manufacturing hiatus. Mahoney said the company will reevaluate its staffing when it resumes full operations. “Certainly, the goal will be, as we get back to full operations, that we would be able to rehire some of those employees,” she said.

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