FDA Inspection 1028354 — Luen Wah (HK) Medicine Ltd
The FDA completed an inspection of Luen Wah (HK) Medicine Ltd on September 28, 2017 in Chai Wan. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 9 citations were issued during this inspection. Product area: Drugs.
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 |