Terumo Cardiovascular Systems (Terumo CVS) received notice from the U.S. Food and Drug Administration that it has successfully completed the second and final phase of its work plan to remediate all products manufactured or distributed from the company’s Ann Arbor, MI manufacturing facility, including Terumo Advanced Perfusion System. As a result, all shipping restrictions, imposed as a term of its 2011 consent decree, are now lifted.
In a letter dated June 8, 2016, the FDA concluded: “Terumo is no longer enjoined under Paragraph 5 of the consent decree from manufacturing, packing, storing, installing, and/or distributing the above listed products from the Ann Arbor Facility.” The letter followed the FDA’s inspection of the facility in early May during which the agency found no inspectional observations.
The Ann Arbor manufacturing facility designs, produces, and distributes electromechanical devices used in cardiac surgery, such as heart-lung machines and blood parameter monitoring systems. The FDA considers some of these devices “life-sustaining,” a category of devices that requires a robust Quality Management System commensurate with such devices.
Terumo CVS agreed to the shipping restrictions in 2011. Under the terms of the consent decree, Terumo CVS would create and execute a work plan to address the FDA’s concerns with the Quality Management System at the Ann Arbor facility. In addition, Terumo CVS would restrict distribution of products manufactured at the plant until the work plan was complete.
The company completed the first phase of a two-phase work plan in December, 2014. After a subsequent inspection of the facility, the FDA determined in February, 2015 that Ann Arbor’s general Quality Management System, as well as processes specific to its CDI Blood Parameter Monitors, were in compliance with regulation and it lifted shipping restrictions on the monitors.
Terumo CVS completed the second and final phase of its work plan in February, leading to the FDA’s inspection in May. It plans to resume distribution of its monitoring systems this summer and expects to scale up production of its heart-lung machines after it completes several engineering projects to manage obsolescence issues.
The consent decree did not impact the production or distribution of products manufactured at the comapny’s other factories, including oxygenators, nor did it impact any other Terumo subsidiary or corporate entity.
Terumo CVS is part of Terumo Cardiovascular Group, one of several subsidiaries of Terumo Corp. of Japan.