1209390
Turncare, Inc — FEI 3013682457
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 26, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Pompton Plains, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |