FDA inspection
American Medical Systems Innovations: FDA inspection ending Feb 27, 2018
FDA inspection 1042434 · Voluntary Action Indicated (VAI) · San Jose, CA
Key facts
| Inspection ID | 1042434 |
|---|---|
| Firm | American Medical Systems Innovations |
| FEI number | 2937094 |
| Address | 3070 Orchard Dr |
| City | San Jose |
| State | CA |
| ZIP | 95134 |
| Country | United States |
| Fiscal year | 2018 |
| Inspection end date | Feb 27, 2018 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Radiation Control and Health Safety Act |
| 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