1061378
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 3, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Zama (Japan)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4303 | 21 CFR 211.67(b) | Written procedures fail to include |