FDA Inspection 751470 — AstraZeneca Pharmaceuticals LP
The FDA completed an inspection of AstraZeneca Pharmaceuticals LP on Oct 28, 2011 in Mount Vernon, IN. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 28, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mount Vernon, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |