FDA inspection
Edwards Lifesciences Technology SARL: FDA inspection ending Apr 15, 2010
FDA inspection 657755 · Voluntary Action Indicated (VAI) · Anasco, PR
Key facts
| Inspection ID | 657755 |
|---|---|
| Firm | Edwards Lifesciences Technology SARL |
| FEI number | 2648045 |
| Address | Hwy # 402 North, Km 1.4 |
| City | Anasco |
| State | PR |
| ZIP | 00610 |
| Country | United States |
| Fiscal year | 2010 |
| Inspection end date | Apr 15, 2010 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: Devices |
| Product type | Devices |
At a glance
- None Citations
- 1–9 Posted citations
- No Warning letter followed
- Yes Form FDA 483 issued
- Yes 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