Gerald B. Blouch, President and CEO of Invacare, and Ronald J. Clines, Invacare’s director of Product Risk and Quality Engineering, signed a consent decree on December 20, 2012 to stop the company from manufacturing or selling wheelchairs or wheelchair components because of persistent violations of FDA Current Good Manufacturing Practices (cGMP). The decree was filed in the United States District Court for the Northern District of Ohio.
The decree prevents Invacare from manufacturing at two facilities in Elyria, Ohio until it corrects violations listed in the consent decree. Invacare has been cited for manufacturing violations in several FDA warnings, including FDA warning letters in 2010 and 2003. Seven inspections since 2002 found numerous violations that the company failed to correct.
The consent decree also requires Invacare to engage outside consultants to help it resolve its persistent manufacturing issues, to develop plans for correcting issues and submit the plans to the FDA. Even if the company receives permission to resume operations, it will be required to submit monthly audit reports to the FDA to ensure continued compliance. This audit requirement will be in place for at least five years after the company begins manufacturing products again.
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