1026110
Sunder Biomedical Tech Co., Ltd. — FEI 3003656001
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- September 13, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Yunlin (Taiwan)
Citations
| ID | CFR | Description |
|---|
| 14710 | 21 CFR 820.150 | Lack of or inadequate procedures for storage. |
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3200 | 21 CFR 820.40(a) | Document locations, Dissemination, etc. |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 3837 | 21 CFR 820.25(b) | Training records |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |