FDA inspection
Aurena Laboratories AB: FDA inspection ending Sep 13, 2019
FDA inspection 1101986 · Voluntary Action Indicated (VAI) · Karlstad
Key facts
| Inspection ID | 1101986 |
|---|---|
| Firm | Aurena Laboratories AB |
| FEI number | 3004080052 |
| Address | Fjarrviksvagen 22 |
| City | Karlstad |
| Country | Sweden |
| Fiscal year | 2019 |
| Inspection end date | Sep 13, 2019 |
| Classification | Voluntary Action Indicated (VAI) |
| 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