FDA inspection
Medexel Co., Ltd.: FDA inspection ending May 26, 2016
FDA inspection 973067 · Voluntary Action Indicated (VAI) · Anseong
Key facts
| Inspection ID | 973067 |
|---|---|
| Firm | Medexel Co., Ltd. |
| FEI number | 3003589279 |
| Address | 252 Geumgwangosan-Ro, Geumgwang-Myeon |
| City | Anseong |
| Country | Korea (the Republic of) |
| Fiscal year | 2016 |
| Inspection end date | May 26, 2016 |
| 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