1245881
SUREPULSE MEDICAL LTD — FEI 3018685978
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 1, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Nottingham (United Kingdom)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |