1236763
Lotus Pharmaceutical Co., Ltd. — FEI 3005999589
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 12, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Nan Tou Xian (Taiwan)
Citations
| ID | CFR | Description |
|---|
| 1033 | 21 CFR 211.22(a) | Authority lacking to review records, investigate errors |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |