Federal Judge Orders Permanent Injunction against Certain Medical Device Manufacturers
The FDA reports that a Federal Judge sitting in the U.S. District Court of New Hampshire entered a consent decree of permanent injunction against four medical device manufacturing companies and two company officers.
Between 2009 and 2013, the U.S. Food and Drug Administration (FDA) conducted ten inspections across the manufacturing sites. Inspections revealed multiple and major violations of the Quality System (QS) regulation, Medical Device Reporting (MDR) regulation, and Correction and Removal (CR) regulation.
After failing to make corrections, the court issued the injunction, which will prevent the manufacturers from distributing adulterated and misbranded medical devices. The decree also requires the manufacturing companies to retain third-party experts to audit and help implement plans to correct violations.
“The American public needs to have the confidence that medical devices on the market are safe and effective,” declares Joyce R. Branda, Acting Assistant Attorney General of the Justice Department’s Civil Division. She adds, “The failure to comply with the quality system regulation for medical devices can pose a serious risk to the public health.”
The reprimanded medical device manufacturers include Atrium Medical Corporation (Atrium), Maquet Holding B.V. & Co. KG (Maquet), Maquet Cardiovascular LLC (Maquet CV), and Maquet Cardiopulmonary AG (Maquet CP). The two company officers named in the consent decree are Heinz Jacqui and Gail Christie.
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