About Terumo Cardiovascular Systems’ Consent Decree
On March 29, 2011, Terumo Cardiovascular Systems (Terumo CVS) entered into a consent decree with the U.S. Food and Drug Administration (FDA) to address improvements to the Quality System at its Ann Arbor, Michigan, facility.
On June 8, 2016, Terumo CVS received notice from the FDA that it had successfully completed the final phase of its work plan to remediate all products manufactured or distributed from the Ann Arbor, Michigan, facility. As a result, all shipping restrictions imposed as a term of the 2011 consent decree were lifted.
With restrictions lifted, Terumo CVS will fully exit the consent decree after five years of surveillance inspections that demonstrate sustained compliance.
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.
- 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.
- Call 1.800.521.2818 (weekdays, 8am-6pm EST)
- Or, send a message via the Contact Us page.