FDA Inspection 1302316 — Janssen Pharmaceutica NV
The FDA completed an inspection of Janssen Pharmaceutica NV on October 7, 2025 in Olen. 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 7, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Olen (Belgium)
Additional Details
Mutual Recognition Agreement (MRA)