FDA inspection
Samsung Bioepis Co., Ltd.: FDA inspection ending Nov 22, 2024
FDA inspection 1255085 · Voluntary Action Indicated (VAI) · Yeonsu
Key facts
| Inspection ID | 1255085 |
|---|---|
| Firm | Samsung Bioepis Co., Ltd. |
| FEI number | 3010031951 |
| Address | 76 Songdogyoyuk-Ro |
| City | Yeonsu |
| Country | Korea (the Republic of) |
| Fiscal year | 2025 |
| Inspection end date | Nov 22, 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