1296688
ZIOSOFT, INC. — FEI 3006621332
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 18, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Minato (Japan)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |