FDA inspection
Outset Medical, Inc.: FDA inspection ending Sep 18, 2024
FDA inspection 1251442 · Voluntary Action Indicated (VAI) · San Jose, CA
Key facts
| Inspection ID | 1251442 |
|---|---|
| Firm | Outset Medical, Inc. |
| FEI number | 3010355846 |
| Address | 3052 Orchard Dr |
| City | San Jose |
| State | CA |
| ZIP | 95134 |
| Country | United States |
| Fiscal year | 2024 |
| Inspection end date | Sep 18, 2024 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- None 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