FDA Accepts Invacare’s First Certification Audit

• By Laurie Watanabe
• May 15, 2013

The U.S. Food & Drug Administration (FDA) has said Invacare Corp.’s first certification audit is acceptable, according to the manufacturer.

In a May 13 announcement, Invacare said the acceptance – related to the qualification and validation documentation for equipment and processes at its Elyria, Ohio, manufacturing facility on Taylor Street – enables Invacare to resume manufacturing and distributing parts, components, accessories and subassemblies to Invacare facilities other than the corporate facility and the facility on Taylor Street.

Invacare has been under an FDA consent decree that limits its production.

Gerald B. Blouch, Invacare’s president/CEO said of the audit acceptance, “This is an important step forward for the company in demonstrating its quality systems’ compliance to the FDA. I am incredibly proud of the Invacare team and all of the work that they have put into improving our quality systems. This is the first critical step in resuming full production at the Taylor Street manufacturing facility.”

Invacare added that the FDA is currently reviewing a second certification audit related to the manufacturer’s design control systems. When the FDA approves that certification report, Invacare will be able to “resume design activities, which will enable it to refocus its engineering resources on new product development,” the news announcement said.

The final certification audit is a third-party audit that Invacare described as “a comprehensive review of the company’s compliance with the FDA’s Quality System Regulation at the impacted Elyria facilities.”

After Invacare submits the third certification audit, the FDA will inspect the Elyria facilities.

“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,” Invacare said.

The manufacturer added that the third certification audit is “well underway.”