FDA inspection
ReliantHeart Inc.: FDA inspection ending Nov 22, 2016
FDA inspection 995475 · Voluntary Action Indicated (VAI) · Houston, TX
Key facts
| Inspection ID | 995475 |
|---|---|
| Firm | ReliantHeart Inc. |
| FEI number | 3003259341 |
| Address | 8965 Interchange Dr |
| City | Houston |
| State | TX |
| ZIP | 77054 |
| Country | United States |
| Fiscal year | 2017 |
| Inspection end date | Nov 22, 2016 |
| 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