FDA Inspection 1291730 — SHANGHAI YOUWEN MEDICAL TECHNOLOGY CO LTD
The FDA completed an inspection of SHANGHAI YOUWEN MEDICAL TECHNOLOGY CO LTD on November 5, 2025 in Shanghai. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 5, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Shanghai (China)
Citations
| ID | CFR | Description |
|---|---|---|
| 3118 | 21 CFR 820.75(a) | Documentation |