1284280
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 |