1245614
Rolence Ent. Inc. — FEI 3002772487
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- July 11, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Chungli (Taiwan)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3132 | 21 CFR 820.120 | Lack of or inadequate procedures for labeling |
| 3159 | 21 CFR 820.184 | DHR content |
| 3680 | 21 CFR 820.70(a) | Process control procedures, Lack of or inadequate procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |