FDA inspection
Helsinn Birex Pharmaceuticals Ltd.: FDA inspection ending Jul 15, 2022
FDA inspection 1272910 · Voluntary Action Indicated (VAI) · Mulhuddart
Key facts
| Inspection ID | 1272910 |
|---|---|
| Firm | Helsinn Birex Pharmaceuticals Ltd. |
| FEI number | 3003724414 |
| Address | Damastown Way |
| City | Mulhuddart |
| Country | Ireland |
| Fiscal year | 2022 |
| Inspection end date | Jul 15, 2022 |
| 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