FDA Inspection 601426 — AstraZeneca Pharmaceuticals LP
The FDA completed an inspection of AstraZeneca Pharmaceuticals LP on Jun 16, 2009 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 16, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Philadelphia, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3591 | 21 CFR 211.110(b) | In-process materials specifications |
| 9086 | 21 CFR 600.14(a)(1) | Who must report - manufacturer |
| 9089 | 21 CFR 600.14(c) | When to report |