FDA inspection
Samsung Biologics Co., Ltd.: FDA inspection ending Nov 1, 2019
FDA inspection 1108244 · Voluntary Action Indicated (VAI) · Yeonsu District
Key facts
| Inspection ID | 1108244 |
|---|---|
| Firm | Samsung Biologics Co., Ltd. |
| FEI number | 3010479596 |
| Address | 300, Songdo Bio Way (Daero), Yeonsu-Gu |
| City | Yeonsu District |
| Country | Korea (the Republic of) |
| Fiscal year | 2020 |
| Inspection end date | Nov 1, 2019 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Drug Quality Assurance |
| Product type | Drugs |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- No Establishment inspection report (EIR) exists
- 10–99 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