1216777
Oishi Koseido Co., Ltd. — FEI 3010166685
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 1, 2023
- Fiscal Year
- 2023
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tosu (Japan)
Citations
| ID | CFR | Description |
|---|
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1496 | 21 CFR 211.122(a) | Sampling/testing of labeling/packaging materials |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |