FDA inspection
Dragon Heart Medical Devices Co., Ltd.: FDA inspection ending Aug 14, 2014
FDA inspection 896796 · Voluntary Action Indicated (VAI) · Kaiping
Key facts
| Inspection ID | 896796 |
|---|---|
| Firm | Dragon Heart Medical Devices Co., Ltd. |
| FEI number | 3004215921 |
| Address | 38 Wujin Road, Baihe Town |
| City | Kaiping |
| Country | China |
| Fiscal year | 2014 |
| Inspection end date | Aug 14, 2014 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: 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