1056547
Kaken Pharmaceutical Co., Ltd. — FEI 3002807376
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 22, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Fujieda (Japan)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1256 | 21 CFR 211.68(b) | Backup file not maintained |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1496 | 21 CFR 211.122(a) | Sampling/testing of labeling/packaging materials |
| 1823 | 21 CFR 211.84(c)(4) | Top/Middle/Bottom container sampling |
| 2014 | 21 CFR 211.188(b)(2) | Identification of Equipment and Lines |
| 4399 | 21 CFR 211.186(b)(7) | Theoretical yield statement including percentages |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |