FDA Inspection 1248311 — Regent Electron (Suzhou) Co., Ltd.
The FDA completed an inspection of Regent Electron (Suzhou) Co., Ltd. on August 15, 2024 in Suzhou. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
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 |