FDA Inspection 1284280 — Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.
The FDA completed an inspection of Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. on Sep 11, 2025 in Taihu. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 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 |