FDA inspection
Lumene Oy: FDA inspection ending Aug 26, 2022
FDA inspection 1178846 · Official Action Indicated (OAI) · Espoo
Key facts
| Inspection ID | 1178846 |
|---|---|
| Firm | Lumene Oy |
| FEI number | 3003908435 |
| Address | Lasikuja 2 |
| City | Espoo |
| Country | Finland |
| Fiscal year | 2022 |
| Inspection end date | Aug 26, 2022 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
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