FDA Inspection 1123956 — Helsinn Birex Pharmaceuticals Ltd.
The FDA completed an inspection of Helsinn Birex Pharmaceuticals Ltd. on October 25, 2019 in Mulhuddart. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 25, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mulhuddart (Ireland)
Additional Details
Mutual Recognition Agreement (MRA)