FDA inspection
Edwards Lifesciences (Singapore) Pte. Ltd: FDA inspection ending Sep 4, 2009
FDA inspection 612135 · Voluntary Action Indicated (VAI) · Singapore
Key facts
| Inspection ID | 612135 |
|---|---|
| Firm | Edwards Lifesciences (Singapore) Pte. Ltd |
| FEI number | 3007063218 |
| Address | 35 Changi North Crescent |
| City | Singapore |
| Fiscal year | 2009 |
| Inspection end date | Sep 4, 2009 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Product Evaluation: Med 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