FDA Inspection 785250 — AstraZeneca UK Ltd.
The FDA completed an inspection of AstraZeneca UK Ltd. on Mar 16, 2012 in Macclesfield. 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
- Mar 16, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Macclesfield (United Kingdom)
Citations
| ID | CFR | Description |
|---|---|---|
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |