FDA inspection
Koo Medical Equipment (Shanghai) Co., Ltd.: FDA inspection ending Sep 12, 2013
FDA inspection 850439 · Voluntary Action Indicated (VAI) · Shanghai
Key facts
| Inspection ID | 850439 |
|---|---|
| Firm | Koo Medical Equipment (Shanghai) Co., Ltd. |
| FEI number | 3003413553 |
| Address | 1 Songjiang Industrial Park, Songjiang |
| City | Shanghai |
| Country | China |
| Fiscal year | 2013 |
| Inspection end date | Sep 12, 2013 |
| 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