FDA inspection
Focalyx Technologies, LLC.: FDA inspection ending Dec 1, 2025
FDA inspection 1293356 · Voluntary Action Indicated (VAI) · Hialeah, FL
Key facts
| Inspection ID | 1293356 |
|---|---|
| Firm | Focalyx Technologies, LLC. |
| FEI number | 3016567400 |
| Address | 2140 W 68th St Ste 204 |
| City | Hialeah |
| State | FL |
| ZIP | 33016 |
| Country | United States |
| Fiscal year | 2026 |
| Inspection end date | Dec 1, 2025 |
| Classification | Voluntary Action Indicated (VAI) |
| Project area | Postmarket Assurance: 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