FDA inspection
Lumenis, Inc.: FDA inspection ending Sep 13, 2016
FDA inspection 986926 · Voluntary Action Indicated (VAI) · Salt Lake City, UT
Key facts
| Inspection ID | 986926 |
|---|---|
| Firm | Lumenis, Inc. |
| FEI number | 1720381 |
| Address | 1870 S Milestone Dr |
| City | Salt Lake City |
| State | UT |
| ZIP | 84104 |
| Country | United States |
| Fiscal year | 2016 |
| Inspection end date | Sep 13, 2016 |
| 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