FDA inspection
SMC Costa Rica Division S.R.L.: FDA inspection ending Jan 30, 2025
FDA inspection 1259544 · Voluntary Action Indicated (VAI) · El Coyol
Key facts
| Inspection ID | 1259544 |
|---|---|
| Firm | SMC Costa Rica Division S.R.L. |
| FEI number | 3009327445 |
| Address | Building B48, Ave 0, Zona Franca Coyol, 100 Mts Al Sur De Rit |
| City | El Coyol |
| Fiscal year | 2025 |
| Inspection end date | Jan 30, 2025 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Product Evaluation: Medical 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