In another January CDRH enforcement action, FDA took 13 days over the height of the holiday season to announce on January 2 that it had signed a consent decree with Invacare Corp. and two of its top executives, president and COO Gerald B. Blouch, and director of product risk and quality engineering Ronald J. Clines. The decree requires the firm to stop manufacturing, designing, and distributing manual and powered wheelchairs and wheelchair components.
Under the decree’s terms, FDA said in a news release, Invacare will not be able to resume normal business operations at two of its Elyria, OH, facilities until it corrects all violations listed in the consent decree and the company has been notified by the FDA that it is in compliance with the FD&C Act.
Seven FDA inspections of the Invacare facilities subject to the consent decree since 2002 have documented violations of FDA’s Quality System regulations, along with failures to properly report adverse events to the agency.
FDA’s decree also requires Invacare to retain a third-party expert to help it develop and submit plans to FDA to correct the violations found by the agency. After Invacare receives permission from FDA to resume manufacturing and distributing, it will have to submit audit reports for 5 years to verify continuing compliance. In addition to these audit inspections, the decree notes that FDA plans to monitor the company’s activities through its own inspections.
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CDRH Roars in January [3]