FDA Inspection 1324332 — Patheon Biologics B.V.
The FDA completed an inspection of Patheon Biologics B.V. on August 21, 2024 in Groningen. 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
- August 21, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Groningen (Netherlands)
Additional Details
Mutual Recognition Agreement (MRA)