FDA inspection
Heartware, Inc.: FDA inspection ending Jan 24, 2014
FDA inspection 864927 · Official Action Indicated (OAI) · Miami Lakes, FL
Key facts
| Inspection ID | 864927 |
|---|---|
| Firm | Heartware, Inc. |
| FEI number | 3007042319 |
| Address | 14400 Nw 60th Ave |
| City | Miami Lakes |
| State | FL |
| ZIP | 33014 |
| Country | United States |
| Fiscal year | 2014 |
| Inspection end date | Jan 24, 2014 |
| Classification | Official Action Indicated (OAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
| Warning letter | 423678 |
At a glance
- 1–9 Citations
- 1–9 Posted citations
- Yes 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