News & Events
FDA NEWS RELEASE
For Immediate Release: Dec. 20, 2012
Media Inquiries: Michelle Bolek, 301-796-2973, email@example.com
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Invacare signs consent decree to correct wheelchair manufacturing problems
The Food and Drug Administration announced today that medical device maker and distributor, Invacare Corp., and two of its top executives have signed a consent decree of permanent injunction requiring the company to stop manufacturing, designing, and distributing manual and powered wheelchairs and wheelchair components.
Once the consent decree is entered into the court, Invacare will not be able to resume normal business operations at two of its Elyria, Ohio, facilities until it corrects 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 Act requires medical device companies to follow current good manufacturing practice and to follow strict guidelines in reporting adverse events to FDA. To comply with current good manufacturing practice, a medical device company must establish and follow specific procedures, which are outlined in FDA’s Quality System regulations, to prevent quality problems in their devices. 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.
“Medical device makers must produce high-quality products and report adverse events to FDA,” said Steve Silverman, director, Office of Compliance, FDA’s Center for Devices and Radiological Health. “Firms that fall short of our requirements risk FDA action to stop distribution of their products.”
The consent 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. Once Invacare receives permission from FDA to resume manufacturing and distributing, the company must continue to submit audit reports to the agency for 5 years to verify continuing compliance. In addition to these audit inspections, the FDA will monitor the company’s activities through its own inspections.
The parties filed the consent decree, which was signed by Gerald B. Blouch, Invacare’s president and chief operating officer, and Ronald J. Clines, the company’s director of Product Risk and Quality Engineering, in the United States District Court for the Northern District of Ohio on Dec. 20, 2012.
If the defendants violate the consent decree, then the FDA may order Invacare to cease manufacturing, recall products, and take other corrective action, and the agency may levy fines of up to $7 million annually.
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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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