FDA issued a Warning Letter to Terumo Cardiovascular Systems on 8/31/2006 as a result of this inspection.
FDA investigators audited the Terumo Cardiovascular Systems - Ann Arbor, MI, United States facility and issued 3 inspectional observations (via FDA 483) on 09 Dec 2005.
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- Category: Medical Devices & Rad Health
- Number of Observations: 3
- Inspection end: 09 Dec 2005
- Location: Ann Arbor, United States
- FEI: 1828100