FDA inspection
Hansen Medical Inc: FDA inspection ending Jun 28, 2010
FDA inspection 669351 · Voluntary Action Indicated (VAI) · Mountain View, CA
Key facts
| Inspection ID | 669351 |
|---|---|
| Firm | Hansen Medical Inc |
| FEI number | 3006026430 |
| Address | 800 E Middlefield Rd |
| City | Mountain View |
| State | CA |
| ZIP | 94043 |
| Country | United States |
| Fiscal year | 2010 |
| Inspection end date | Jun 28, 2010 |
| Classification | Voluntary Action Indicated (VAI) |
| 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
- 1–9 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