FDA Inspection 1334174 — AstraZeneca AB
The FDA completed an inspection of AstraZeneca AB on Dec 12, 2025 in Sodertalje. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 12, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sodertalje (Sweden)
Additional Details
Mutual Recognition Agreement (MRA)