FDA Inspection 1117000 — Alexion Pharma International Operations Unlimited Co.
The FDA completed an inspection of Alexion Pharma International Operations Unlimited Co. on October 25, 2019 in Athlone. 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
- Athlone (Ireland)
Additional Details
Mutual Recognition Agreement (MRA)