FDA inspection
SHAPE MEMORY MEDICAL INC: FDA inspection ending Mar 13, 2025
FDA inspection 1264622 · Voluntary Action Indicated (VAI) · San Jose, CA
Key facts
| Inspection ID | 1264622 |
|---|---|
| Firm | SHAPE MEMORY MEDICAL INC |
| FEI number | 3013353964 |
| Address | 1321 Ridder Park Dr Ste 10 |
| City | San Jose |
| State | CA |
| ZIP | 95131 |
| Country | United States |
| Fiscal year | 2025 |
| Inspection end date | Mar 13, 2025 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: 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