FDA inspection
Shanghai ISO Medical Products Co., Ltd.: FDA inspection ending Nov 16, 2023
FDA inspection 1224750 · Voluntary Action Indicated (VAI) · Shanghai
Key facts
| Inspection ID | 1224750 |
|---|---|
| Firm | Shanghai ISO Medical Products Co., Ltd. |
| FEI number | 3004022422 |
| Address | 999 Liuchen Road, Pudongxin |
| City | Shanghai |
| Country | China |
| Fiscal year | 2024 |
| Inspection end date | Nov 16, 2023 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Devices |
| Product type | Devices |
At a glance
- None 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