FDA inspection
Helsinn Birex Pharmaceuticals Ltd.: FDA inspection ending Oct 25, 2019
FDA inspection 1123956 · Voluntary Action Indicated (VAI) · Mulhuddart
Key facts
| Inspection ID | 1123956 |
|---|---|
| Firm | Helsinn Birex Pharmaceuticals Ltd. |
| FEI number | 3003724414 |
| Address | Damastown Industrial Estate |
| City | Mulhuddart |
| Country | Ireland |
| Fiscal year | 2020 |
| Inspection end date | Oct 25, 2019 |
| 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