FDA Inspection 1175133 — AstraZeneca Pharmaceuticals LP
The FDA completed an inspection of AstraZeneca Pharmaceuticals LP on Jul 22, 2022 in Philadelphia, PA. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 22, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Philadelphia, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |