1026084
Wong Lap Kwong Medicine Company Limited — FEI 3003338476
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 22, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Sham Shui Po (Hong Kong SAR)
Citations
| ID | CFR | Description |
|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1219 | 21 CFR 211.67(b)(2) | Cleaning SOPs/schedules |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1411 | 21 CFR 211.105(b) | Distinctive ID or code not recorded in batch record |
| 1448 | 21 CFR 211.111 | Establishment of time limitations |
| 1456 | 21 CFR 211.115(b) | Reprocessing/quality control unit |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 1825 | 21 CFR 211.84(c)(6) | Identifying Containers Sampled |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 1845 | 21 CFR 211.84(d)(3) | Container/Closure Written Test Procedure |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |
| 3607 | 21 CFR 211.160(b)(2) | Acceptance of in-process materials |
| 3611 | 21 CFR 211.160(b)(3) | Acceptance of drug products |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4327 | 21 CFR 211.122(c) | Records fail to include |
| 4330 | 21 CFR 211.130(e) | Packaging line inspection documentation |
| 4366 | 21 CFR 211.188(a) | Accurate reproduction included |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |