1095778
RePharm LLC — FEI 3015474688
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 3, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Riverside, MO (United States)
Citations
| ID | CFR | Description |
|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1633 | 21 CFR 211.130(d) | Examination of packaging and labeling |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |