FDA Inspection 1218331 — AstraZeneca Pharmaceuticals LP
The FDA completed an inspection of AstraZeneca Pharmaceuticals LP on September 19, 2023 in Mount Vernon, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 19, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mount Vernon, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |