Atrium Medical Corporation and three other affiliated Maquet companies reached an agreement concerning a Consent Decree (Decree) with the U.S. Food and Drug Administration (FDA). This voluntary agreement was approved by a federal judge in New Hampshire on February 3rd, 2015 and establishes a framework that provides assurances to the FDA that the company will complete the improvements currently underway to strengthen its quality management system.
The Decree provides a clear path forward for the company to complete the enhancement of its quality management system and to continue to provide products of the highest medical quality.
There was no indication that any of the products involved in the case were unsafe. The Decree did not require Atrium or Maquet to remove, recall or perform corrective actions on any products currently in the market or at any of our distribution facilities.
- Atrium Medical Corporation has successfully transitioned a portion of their manufacturing operations in Hudson, NH to a new facility in Merrimack, NH, thus lifting the requirement for CMN on certain products, including iCAST. For more details, click here.
- Manufacturing of certain products at Atrium’s facilities in Hudson, New Hampshire were suspended. The production of some of these products has been moved to our new manufacturing site in Merrimack, NH. Some of these products were temporarily unavailable once existing inventory located at our distribution facilities was exhausted.
- Certain products currently manufactured at Atrium’s Hudson facilities have been deemed medically necessary under the Decree and will continue to be made available to customers inside and outside of the U.S., provided that an authorized representative of the customer signs a Certificate of Medical Necessity form.
- Operations at three Maquet locations that also fall under the Decree – Wayne, New Jersey and Rastatt and Hechingen, Germany – will be subject to additional inspections, but will continue to produce and distribute products globally.
- All other Maquet locations and companies inside and outside of the U.S. are not part of this Decree.
For continued access to medically necessary products, please review Atrium’s Notification Guide, which explains product availability in detail and which contains the Certificate of Medical Necessity Form. For an update regarding current inspections please review: Progress Report.