FDA inspection
Samsung Bioepis Co., Ltd.: FDA inspection ending Nov 6, 2017
FDA inspection 1042286 · No Action Indicated (NAI) · Yeonsu
Key facts
| Inspection ID | 1042286 |
|---|---|
| Firm | Samsung Bioepis Co., Ltd. |
| FEI number | 3010031951 |
| Address | Samseongbaioepiseu(Ju), Cheomdandae-Ro 107/107 |
| City | Yeonsu |
| Fiscal year | 2018 |
| Inspection end date | Nov 6, 2017 |
| Classification | No Action Indicated (NAI) |
| Project area | Generic Drug Evaluation |
| Product type | Drugs |
At a glance
- None Citations
- None Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes 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