FDA inspection
Regent Electron (Suzhou) Co., Ltd.: FDA inspection ending Aug 15, 2024
FDA inspection 1248311 · Official Action Indicated (OAI) · Suzhou
Key facts
| Inspection ID | 1248311 |
|---|---|
| Firm | Regent Electron (Suzhou) Co., Ltd. |
| FEI number | 3012404027 |
| Address | 888 Pang Donglu, Wujiang |
| City | Suzhou |
| Country | China |
| Fiscal year | 2024 |
| Inspection end date | Aug 15, 2024 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 1–9 Inspections at this FEI
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA inspections
FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.
Source: U.S. Food and Drug Administration (FDA), inspection classification data