1249532
Sweden & Martina Spa — FEI 3001082453
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 1, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Due Carrare (Italy)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |