FDA Inspection 1026084 — Wong Lap Kwong Medicine Company Limited
The FDA completed an inspection of Wong Lap Kwong Medicine Company Limited on September 22, 2017 in Sham Shui Po. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 24 citations were issued during this inspection. Product area: Drugs.
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 |