FDA inspection
Shockwave Medical, Inc.: FDA inspection ending Oct 9, 2019
FDA inspection 1108199 · No Action Indicated (NAI) · Santa Clara, CA
Key facts
| Inspection ID | 1108199 |
|---|---|
| Firm | Shockwave Medical, Inc. |
| FEI number | 3015053858 |
| Address | 5403 Betsy Ross Dr |
| City | Santa Clara |
| State | CA |
| ZIP | 95054 |
| Country | United States |
| Fiscal year | 2020 |
| Inspection end date | Oct 9, 2019 |
| Classification | No Action Indicated (NAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- None Citations
- None Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes 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