FDA inspection
PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD.: FDA inspection ending Jun 26, 2025
FDA inspection 1275470 · Voluntary Action Indicated (VAI) · Changzhou
Key facts
| Inspection ID | 1275470 |
|---|---|
| Firm | PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD. |
| FEI number | 3007539489 |
| Address | Gdh Industrial Park 3a, No. 16 Chuangye Road; Chunjiangzhen Xinbei District |
| City | Changzhou |
| Country | China |
| Fiscal year | 2025 |
| Inspection end date | Jun 26, 2025 |
| 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