1274346
Contec Medical Systems Co., Ltd. — FEI 3006979678
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 12, 2025
- Fiscal Year
- 2025
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Qinhuangdao (China)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3149 | 21 CFR 820.180 | Availability |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |