FDA inspection
Oncotec Pharma Produktion GmbH: FDA inspection ending Sep 3, 2021
FDA inspection 1172380 · Voluntary Action Indicated (VAI) · Dessau Rosslau
Key facts
| Inspection ID | 1172380 |
|---|---|
| Firm | Oncotec Pharma Produktion GmbH |
| FEI number | 3009238374 |
| Address | Am Pharmapark |
| City | Dessau Rosslau |
| Country | Germany |
| Fiscal year | 2021 |
| Inspection end date | Sep 3, 2021 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
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