Terumo Corp. (TYO:4543) said today it received a notice from the FDA lifting all shipping restrictions at its Ann Arbor, Mich. facility that were imposed in 2011 as part of the company’s consent decree.
The step is the 2nd and final phase of the company’s work plan to remediate products manufactured at the facility to comply with the FDA’s requirements, Terumo said.
“This means we have demonstrated to the FDA that we have the Quality System and infrastructure needed to manufacture life-sustaining devices in full compliance with the FDA regulation. But most importantly for all of our employees and our customers, it means that our Ann Arbor facility is now stronger and in a better position to serve our customers. We are looking forward to fulfilling our company’s mission of helping save lives,” CEO Mark Sutter said in a press release.
The federal watchdog performed an inspection in May and reported that it found “no inspectional observations,” Terumo said.
“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 FDA wrote in a letter to Terumo, dated June 8.
The facility in Ann Arbor designs, produces and distributes electromechanical devices used in cardiac surgery, the company said, which the FDA considers to be ‘life-sustaining’ and therefore requires “a robust quality management system commensurate with these types of devices,” Terumo said.
The company agreed to the restrictions in 2011 as part of its consent decree, in which it pledged to create and execute a work plan to handle the FDA’s concerns about its quality management system.
The 1st phase of the work plan was completed in December 2014, and the final phase was completed in February with a follow-up inspection in May.