FDA Inspection 1316666 — AGC Biologics A/S
The FDA completed an inspection of AGC Biologics A/S on June 29, 2023 in Soborg. 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
- June 29, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Soborg (Denmark)
Additional Details
Mutual Recognition Agreement (MRA)