FDA inspection
Sewoon Medical Co., Ltd.: FDA inspection ending Jun 23, 2011
FDA inspection 733070 · Voluntary Action Indicated (VAI) · Cheonan
Key facts
| Inspection ID | 733070 |
|---|---|
| Firm | Sewoon Medical Co., Ltd. |
| FEI number | 3000247987 |
| Address | 344-14 Chungcheongnam-Do, Dorim-Ri, Ipjang-Myeon, Seobuk-Gu |
| City | Cheonan |
| Country | Korea (the Republic of) |
| Fiscal year | 2011 |
| Inspection end date | Jun 23, 2011 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
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
- 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