FDA Inspection 1280210 — Carbogen Amcis B.V.
The FDA completed an inspection of Carbogen Amcis B.V. on November 9, 2022 in Veenendaal. 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 9, 2022
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Veenendaal (Netherlands)
Additional Details
Mutual Recognition Agreement (MRA)