FDA Inspection 1274837 — Hysan Pharmaceutical Co., Ltd.
The FDA completed an inspection of Hysan Pharmaceutical Co., Ltd. on Jun 12, 2025 in Chai Wan. 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 12, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Chai Wan (Hong Kong SAR)
Citations
| ID | CFR | Description |
|---|---|---|
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 21296 | 21 CFR 211.186(a) | Master production and control records, batch uniformity |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |