FDA Inspection 1274836 — Fortune Pharmacal Company Ltd
The FDA completed an inspection of Fortune Pharmacal Company Ltd on June 6, 2025 in Yuen Long. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 6, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Yuen Long (Hong Kong SAR)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 4305 | 21 CFR 211.68(b) | Backup data not assured as exact and complete |