Terumo Cardiovascular Group
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Questions or concerns about the Terumo CVS' Consent Decree?
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About Terumo Cardiovascular Systems' Consent Decree
On March 22, 2011, Terumo Cardiovascular Systems (Terumo CVS) announced that it had agreed on the terms of a consent decree with the U.S. Food and Drug Administration (FDA) regarding improvements to the Quality System at the company's Ann Arbor, Michigan, facility. (See media release.) The decree went into effect on March 29, 2011.
Terumo CVS is pleased to announce that it received notice from the FDA that it successfully completed the second and final phase of its work plan to remediate all products manufactured or distributed from Terumo's Ann Arbor, Michigan, manufacturing facility, including Terumo® Advanced Perfusion System 1.
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."
This follows the February 2015 notification that the general Quality Systems and the CDI® Blood Parameter Monitoring System 500 hardware were in compliance with the FDA regulations.
As a result, all shipping restrictions imposed as a term of its 2011 consent decree are lifted.
Throughout this rigorous process, Terumo CVS has reinforced its commitment to patient safety and product quality, and the medical community it serves:
- The Ann Arbor Quality System is compliant with the Quality System Regulation and current Good Manufacturing Practices, and drives continuous process improvements.
- The company recognizes the role of today's more stringent regulatory environment and is ready to meet the challenges of an intense regulatory landscape.
- The company has emerged stronger, smarter, more agile and more compliant — well positioned to meet regulatory requirements today and in the future.
- Throughout this challenging period, company employees have retained their relentless commitment to serving customers and patients in the CV OR.
- Terumo CVS remains committed to its mission to become the world's most trusted provider of its portfolio of CV OR products.