FDA inspection
Shin Chang Medical Co., Ltd.: FDA inspection ending Dec 5, 2024
FDA inspection 1256912 · Voluntary Action Indicated (VAI) · Gumi
Key facts
| Inspection ID | 1256912 |
|---|---|
| Firm | Shin Chang Medical Co., Ltd. |
| FEI number | 3003169040 |
| Address | 144 1gongdan-Ro 6-Gil |
| City | Gumi |
| Country | Korea (the Republic of) |
| Fiscal year | 2025 |
| Inspection end date | Dec 5, 2024 |
| 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