1028354
Luen Wah (HK) Medicine Ltd — FEI 3004962092
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 28, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chai Wan (Hong Kong SAR)
Citations
| ID | CFR | Description |
|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4314 | 21 CFR 211.84(d)(2) | Reports of Analysis (Components) |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |
| 4576 | 21 CFR 211.192 | No written record of investigation |