1178651
Opto-Pharm Pte Ltd. — FEI 3005320466
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 1, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Singapore (Singapore)
Citations
| ID | CFR | Description |
|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1435 | 21 CFR 211.42(c)(10)(v) | Cleaning System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3565 | 21 CFR 211.58 | Buildings not maintained in good state of repair |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |