FDA inspection
PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD.: FDA inspection ending Oct 27, 2016
FDA inspection 992391 · Voluntary Action Indicated (VAI) · Changzhou
Key facts
| Inspection ID | 992391 |
|---|---|
| Firm | PARAGON MEDICAL DEVICE (CHANGZHOU) CO., LTD. |
| FEI number | 3007539489 |
| Address | Gdh Industrial Park 3A , NO. 16 Chuangye Road; Xinbei |
| City | Changzhou |
| Country | China |
| Fiscal year | 2017 |
| Inspection end date | Oct 27, 2016 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: 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