FDA inspection
BrightGene Pharmaceutical Co., Ltd.: FDA inspection ending Apr 26, 2024
FDA inspection 1240231 · Voluntary Action Indicated (VAI) · Suzhou
Key facts
| Inspection ID | 1240231 |
|---|---|
| Firm | BrightGene Pharmaceutical Co., Ltd. |
| FEI number | 3009867839 |
| Address | Suzhou Industrial Park, Floor C28, C27, C26, C25, No. 218 Xinghu Road; Linhuzhen Wuzhong |
| City | Suzhou |
| Country | China |
| Fiscal year | 2024 |
| Inspection end date | Apr 26, 2024 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| 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