After conducting 10 inspections and overseeing 45 recalls on devices made by Germany's Maquet Holding, and repeatedly citing it for violations of the Quality System good manufacturing regulation, Medical Device Reporting regulation, and others, the FDA has had enough.
|The Flixene vascular graft is one of the devices being temporarily suspended under the consent decree.--Courtesy of Maquet|
It requested and obtained a consent decree from a federal court that closes the company's Hudson, NH, manufacturing facility. The company may manufacture and distribute certain devices if its customers sign a Certificate of Medical Necessity, the FDA said in a release. But it also lists 5 Maquet devices that will be temporarily suspended from the market, including three brands of hernia mesh, a vascular graft and a vascular patch.
"The American public needs to have the confidence that medical devices on the market are safe and effective," said Acting Assistant Attorney General Joyce Branda of the Justice Department's Civil Division in a statement. "The failure to comply with the quality system regulation for medical devices can pose a serious risk to the public health."
Maquet, a subsidiary of Sweden's Getinge Group, acquired the New Hampshire facility in the $680 million acquisition of Atrium Medical in 2011.
In addition, Maquet companies, including Maquet Cardiovascular of New Jersey and Maquet Cardiopulmonary AG of Germany must retain third-party experts to conduct inspections or audits and implement plans to correct regulatory violations, the FDA said.
The FDA says it issued two warning letters to Maquet between 2009 and 2013.
"Patients must be assured that medical devices are safe, effective and high quality," said Jan Welch, acting director of the Office of Compliance in the FDA's device arm (CDRH), in a statement. "The FDA will remain vigilant in bringing companies that do not meet our regulatory requirements back to a sustainable state of compliance."
Adding insult to injury, Maquet must also pay the feds $6 million.
Maquet CEO Heinz Jacqui and Maquet compliance officer Gail Christie were also named in the consent decree of permanent injunction.
- read the release from the FDA | read the release from the DOJ