1182039
Jazz Imaging — FEI 3013503781
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 24, 2022
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- San Jose, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3262 | 21 CFR 820.250(a) | Statistical techniques - Lack of or inadequate procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 3683 | 21 CFR 820.70(g) | Equipment Installation, Placement, Specified Requirements |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 4060 | 21 CFR 820.20(b)(3)(i) | Management representative implementing the quality system |