FDA inspection
Abbott Medical Costa Rica Ltda: FDA inspection ending May 19, 2016
FDA inspection 983549 · Voluntary Action Indicated (VAI) · Alajuela
Key facts
| Inspection ID | 983549 |
|---|---|
| Firm | Abbott Medical Costa Rica Ltda |
| FEI number | 3008452825 |
| Address | Abbott Electrophysiology Unit, Zona Franca Coyol, Edificio #44, Calle 0 Ave 2 |
| City | Alajuela |
| Country | Costa Rica |
| Fiscal year | 2016 |
| Inspection end date | May 19, 2016 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Compliance: 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