FDA Inspection 1305248 — Novartis Manufacturing NV
The FDA completed an inspection of Novartis Manufacturing NV on March 5, 2025 in Puurs-Sint-Amands. 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
- March 5, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Puurs-Sint-Amands (Belgium)
Additional Details
Mutual Recognition Agreement (MRA)