Progress Reports

On March 29, 2011, Terumo Cardiovascular Systems entered into a consent decree with the US Food and Drug Administration (FDA) to address deficiencies in the Quality System at its Ann Arbor plant.   Since then, the company has made steady progress fulfilling its commitments to the terms of the decree.

Since mid-summer 2011, Terumo CVS has been focused on designing and building a new Quality System, a large-scale project and the core of its ongoing work. 

January 2012 milestones to-date:

• Terumo CVS has created approximately 200 new positions focused on Quality System compliance.  This is an increase of approximately 40% in the number of Ann Arbor-based employees.
• Terumo CVS hired an independent third-party to perform a comprehensive inspection of the Quality System (and subsequent inspections as noted).
• Terumo CVS has developed a work plan, a highly-detailed roadmap for transforming every aspect of the Quality System. FDA has approved the work plan.
• Of the more than 650 discrete action items to be delivered by the work plan, Terumo CVS has a 100% on-time completion rate as of January 2012.  This has been documented and reported by the independent third-party. 

Download a progress report:
           Customer Update: Progress at the Speed of Right, January 2012

Milestones in Terumo CVS Consent Decree
(Enlarge timeline)