1248311
Regent Electron (Suzhou) Co., Ltd. — FEI 3012404027
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 15, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Suzhou (China)
Citations
| ID | CFR | Description |
|---|
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |
| 3328 | 21 CFR 820.180(b) | Retention period |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |