FDA Inspection 1222279 — Gentium SRL
The FDA completed an inspection of Gentium SRL on December 17, 2021 in Villa Guardia. 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 17, 2021
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Villa Guardia (Italy)
Additional Details
Mutual Recognition Agreement (MRA)