FDA inspection
Terumo Cardiovascular Systems Corporation: FDA inspection ending Feb 17, 2014
FDA inspection 868020 · Official Action Indicated (OAI) · Ann Arbor, MI
Key facts
| Inspection ID | 868020 |
|---|---|
| Firm | Terumo Cardiovascular Systems Corporation |
| FEI number | 1828100 |
| Address | 6200 Jackson Rd |
| City | Ann Arbor |
| State | MI |
| ZIP | 48103 |
| Country | United States |
| Fiscal year | 2014 |
| Inspection end date | Feb 17, 2014 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 10–99 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data