FDA inspection
BrightGene Bio-Medical Technology Co., Ltd.: FDA inspection ending Aug 10, 2023
FDA inspection 1216401 · Voluntary Action Indicated (VAI) · Suzhou
Key facts
| Inspection ID | 1216401 |
|---|---|
| Firm | BrightGene Bio-Medical Technology Co., Ltd. |
| FEI number | 3012595938 |
| Address | Suzhou Industrial Park, 218 Xinghu Road; Linhuzhen Wuzhong |
| City | Suzhou |
| Fiscal year | 2023 |
| Inspection end date | Aug 10, 2023 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Generic Drug Evaluation |
| Product type | Drugs |
At a glance
- None 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