FDA inspection
BrightGene Pharmaceutical Co., Ltd: FDA inspection ending Jan 25, 2024
FDA inspection 1227980 · Voluntary Action Indicated (VAI) · Suzhou
Key facts
| Inspection ID | 1227980 |
|---|---|
| Firm | BrightGene Pharmaceutical Co., Ltd |
| FEI number | 3023102835 |
| Address | Suzhou Industrial Park, No. 278 Jiangyun Road |
| City | Suzhou |
| Fiscal year | 2024 |
| Inspection end date | Jan 25, 2024 |
| 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