1238217
Criticare Technologies, Inc. — FEI 3012238587
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 10, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Warwick, RI (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14716 | 21 CFR 820.30(f) | Design verification - output does not meet input requirement |
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate 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 |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3837 | 21 CFR 820.25(b) | Training records |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |