1152056
CardioQuip, LLC — FEI 3007899424
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 17, 2021
- Fiscal Year
- 2021
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- College Station, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14714 | 21 CFR 820.30(c) | Design input - Lack of or inadequate procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3170 | 21 CFR 820.198(b) | Review and evaluation for investigation |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3372 | 21 CFR 820.198(d) | Records of MDR Investigation |
| 3674 | 21 CFR 820.30(d) | Design output - documentation |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |