FDA Inspection 1274838 — Po Sum On Medicine Factory Limited
The FDA completed an inspection of Po Sum On Medicine Factory Limited on June 18, 2025 in Aberdeen. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 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 |