FDA Inspection 936026 — AstraZeneca Nijmegen B.V.
The FDA completed an inspection of AstraZeneca Nijmegen B.V. on Jun 5, 2015 in Nijmegen. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 5, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Nijmegen (Netherlands)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4344 | 21 CFR 211.160(b)(1) | Sampling and testing procedures described |