Company
United StatesFocalyx Technologies, Hialeah, FL – FDA Inspections
Inspection records and compliance data for Focalyx Technologies in Hialeah, Florida. 2 FDA inspections on record, 1 Form 483, last inspected December 01, 2025.
Company Profile
This profile covers Focalyx Technologies based in Hialeah, Florida, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 0
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected August 14, 2023. Last inspected December 1, 2025.
Most cited issue areas
- Design validation - user needs and intended uses1 inspection
- Label to bear a unique device identifier1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 1, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Medical Devices | 1293356 |
| August 14, 2023 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1220060 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Focalyx Technologies
FEI Number
3016567400
Address
2140 W 68th St Ste 204, Hialeah, Florida 33016, United States
Country
United States
ID: fe709d40-ab14-4517-92ea-5dd88985ab6a