FDA Inspection 782402 — Peking Medicine Manufactory
The FDA completed an inspection of Peking Medicine Manufactory on April 30, 2012 in Tsuen Wan. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 15 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 30, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tsuen Wan (Hong Kong SAR)
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1169 | 21 CFR 211.42(a) | Buildings of Suitable Size, Construction, Location |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1550 | 21 CFR 211.125(f) | Procedures Written and Followed |
| 1774 | 21 CFR 211.142(a) | Quarantine - actual practice |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1791 | 21 CFR 211.80(c) | Storage off Floor, Spaced Suitably |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 4325 | 21 CFR 211.110(a) | Control procedures fail to include the following |
| 4340 | 21 CFR 211.142 | Written warehousing procedures established/followed |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |