FDA Inspection 1152317 — Novartis Manufacturing NV
The FDA completed an inspection of Novartis Manufacturing NV on April 29, 2021 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
- April 29, 2021
- Fiscal Year
- 2021
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Puurs-Sint-Amands (Belgium)
Additional Details
Mutual Recognition Agreement (MRA)