FDA inspection
Edwards Lifesciences, LLC: FDA inspection ending Feb 22, 2013
FDA inspection 819579 · Official Action Indicated (OAI) · Draper, UT
Key facts
| Inspection ID | 819579 |
|---|---|
| Firm | Edwards Lifesciences, LLC |
| FEI number | 1713910 |
| Address | 12050 S Lone Peak Pkwy |
| City | Draper |
| State | UT |
| ZIP | 84020 |
| Country | United States |
| Fiscal year | 2013 |
| Inspection end date | Feb 22, 2013 |
| Classification | Official Action Indicated (OAI) |
| Project area | Project Evaluation: Devices |
| Product type | Devices |
| Warning letter | 394817 |
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
- 10–99 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