FDA inspection
Edwards Lifesciences AG: FDA inspection ending Mar 30, 2017
FDA inspection 1020193 · No Action Indicated (NAI) · Haina, San Cristobal
Key facts
| Inspection ID | 1020193 |
|---|---|
| Firm | Edwards Lifesciences AG |
| FEI number | 3003081151 |
| Address | Parque Industrial Itabo, Km. 18.5 Carr. Sanchez |
| City | Haina, San Cristobal |
| Fiscal year | 2017 |
| Inspection end date | Mar 30, 2017 |
| Classification | No Action Indicated (NAI) |
| Project area | Compliance: Medical Devices |
| Product type | Devices |
At a glance
- None Citations
- None 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