FDA Inspection 1274838 — Po Sum On Medicine Factory Limited
The FDA completed an inspection of Po Sum On Medicine Factory Limited on Jun 18, 2025 in Aberdeen. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 18, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Aberdeen (Hong Kong SAR)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1958 | 21 CFR 211.180(f) | Responsible firm officials notified in writing |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |