FDA Inspection 1327698 — Carbogen Amcis AG
The FDA completed an inspection of Carbogen Amcis AG on November 14, 2025 in Bubendorf. 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
- November 14, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Bubendorf (Switzerland)
Additional Details
Mutual Recognition Agreement (MRA)