FDA Inspection 1293356 — Focalyx Technologies, LLC.
The FDA completed an inspection of Focalyx Technologies, LLC. on Dec 1, 2025 in Hialeah, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Dec 1, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Hialeah, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22795 | 21 CFR 801.20(a) | Label to bear a unique device identifier |
| 3192 | 21 CFR 820.30(g) | Design validation - user needs and intended uses |