FDA inspection
Heartware, Inc.: FDA inspection ending Jul 12, 2018
FDA inspection 1058645 · Official Action Indicated (OAI) · Miami Lakes, FL
Key facts
| Inspection ID | 1058645 |
|---|---|
| Firm | Heartware, Inc. |
| FEI number | 3007042319 |
| Address | 14400 Nw 60th Ave |
| City | Miami Lakes |
| State | FL |
| ZIP | 33014 |
| Country | United States |
| Fiscal year | 2018 |
| Inspection end date | Jul 12, 2018 |
| Classification | Official Action Indicated (OAI) |
| 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