FDA inspection
Simtra Deutschland GmbH: FDA inspection ending Sep 26, 2025
FDA inspection 1283802 · Official Action Indicated (OAI) · Halle (Westf.)
Key facts
| Inspection ID | 1283802 |
|---|---|
| Firm | Simtra Deutschland GmbH |
| FEI number | 3002806419 |
| Address | Kant Str. 2 |
| City | Halle (Westf.) |
| Country | Germany |
| Fiscal year | 2025 |
| Inspection end date | Sep 26, 2025 |
| Classification | Official Action Indicated (OAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
| Warning letter | 720436 |
At a glance
- 10–99 Citations
- 1–9 Posted citations
- Yes Warning letter followed
- Yes Form FDA 483 issued
- Yes Establishment inspection report (EIR) exists
- 10–99 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