FDA inspection
Dragon Heart Medical Inc.: FDA inspection ending Apr 24, 2018
FDA inspection 1049530 · Voluntary Action Indicated (VAI) · Elmhurst, IL
Key facts
| Inspection ID | 1049530 |
|---|---|
| Firm | Dragon Heart Medical Inc. |
| FEI number | 3004735647 |
| Address | 300 W Lake St Ste 204 |
| City | Elmhurst |
| State | IL |
| ZIP | 60126 |
| Country | United States |
| Fiscal year | 2018 |
| Inspection end date | Apr 24, 2018 |
| 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