FDA inspection
ShinChang Medical Co., Ltd.: FDA inspection ending Jun 10, 2004
FDA inspection 333164 · Official Action Indicated (OAI) · Gumi
Key facts
| Inspection ID | 333164 |
|---|---|
| Firm | ShinChang Medical Co., Ltd. |
| FEI number | 3003169040 |
| Address | 144 1gongdan-Ro |
| City | Gumi |
| Fiscal year | 2004 |
| Inspection end date | Jun 10, 2004 |
| Classification | Official Action Indicated (OAI) |
| Project area | Compliance: Med 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