FDA Inspection 1319840 — OLEON N.V.
The FDA completed an inspection of OLEON N.V. on December 13, 2023 in Venette. 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
- December 13, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Venette (France)
Additional Details
Mutual Recognition Agreement (MRA)