According to an FDA news release, Elyria, Ohio-based company Invacare has signed a consent decree, calling for the company to correct wheelchair manufacturing issues. The consent decree of permanent injunction requires Invacare to stop manufacturing, designing, and distributing manual and powered wheelchairs and wheelchair components. The consent decree was signed December 20 by Gerald B. Blouch, Invacare president and COO, and Ronald J. Clines, the company’s director of Product Risk and Quality Engineering.
Upon the consent decree’s entry into court, the FDA says, Invacare will be unable to resume normal business operations at two of its Elyria-based facilities until it has corrected all violations listed in the consent decree and it has been notified by the FDA that it is in compliance with the Federal Food, Drug, and Cosmetic Act (the Act).
The FDA reports that the Act calls for device companies to follow current good manufacturing practice and to follow strict guidelines in reporting adverse events to the FDA. The release notes that the consent decree also requires Invacare to retain a third-party expert to assist in developing and submitting plans to the FDA in order to correct the violations found by the agency. After receiving FDA approval to resume manufacturing and distributing, the company must continue to submit audit reports to the agency for 5 years to verify continuing compliance. The FDA reports that it will also monitor Invacare’s activities through its own inspections.
For more information, visit www.fda.gov.
To read a company news release from Invacare regarding the consent decree, click here.