FDA inspection
ESTABLISHMENT LABS SA: FDA inspection ending Feb 24, 2017
FDA inspection 1014107 · Voluntary Action Indicated (VAI) · Coyol Free Zone
Key facts
| Inspection ID | 1014107 |
|---|---|
| Firm | ESTABLISHMENT LABS SA |
| FEI number | 3012883202 |
| Address | Coyol Free Zone & Business Park Building, 4th Street, Building B-15 |
| City | Coyol Free Zone |
| Fiscal year | 2017 |
| Inspection end date | Feb 24, 2017 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: Medical Devices |
| Product type | Devices |
At a glance
- None 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