FDA inspection
Lumedx: FDA inspection ending Apr 20, 2017
FDA inspection 1022340 · Voluntary Action Indicated (VAI) · Bellevue, WA
Key facts
| Inspection ID | 1022340 |
|---|---|
| Firm | Lumedx |
| FEI number | 3008012314 |
| Address | 110 110th Ave NE Ste 475 |
| City | Bellevue |
| State | WA |
| ZIP | 98004-5884 |
| Fiscal year | 2017 |
| Inspection end date | Apr 20, 2017 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Medical 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