FDA Inspection 1284280 — Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
The FDA completed an inspection of Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. on September 11, 2025 in Taihu. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 11, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Taihu (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3270 | 21 CFR 820.80(c) | Documentation |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 4070 | 21 CFR 820.30(g) | Design validation - documentation |