FDA inspection
Shanghai Henlius Biopharmaceuticals Co., Ltd.: FDA inspection ending Aug 18, 2023
FDA inspection 1256189 · Voluntary Action Indicated (VAI) · Shanghai
Key facts
| Inspection ID | 1256189 |
|---|---|
| Firm | Shanghai Henlius Biopharmaceuticals Co., Ltd. |
| FEI number | 3016529861 |
| Address | Whole Building, 1289 Yishan Road |
| City | Shanghai |
| Country | China |
| Fiscal year | 2023 |
| Inspection end date | Aug 18, 2023 |
| 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