1293926
Cryo-Dynamics, Inc. — FEI 3030478415
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 4, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Southlake, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |