FDA inspection
Edwards Lifesciences Technology SARL: FDA inspection ending Jun 11, 2019
FDA inspection 1093287 · Voluntary Action Indicated (VAI) · Anasco, PR
Key facts
| Inspection ID | 1093287 |
|---|---|
| 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 | 2019 |
| Inspection end date | Jun 11, 2019 |
| Classification | Voluntary Action Indicated (VAI) |
| 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