1283264
Nippon Shikizai, Inc. — FEI 3012051074
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 12, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tsukuba (Japan)
Citations
| ID | CFR | Description |
|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1920 | 21 CFR 211.166(a)(3) | Valid stability test methods |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |