# FDA 483 - Focalyx Technologies - December 01, 2025

Source: https://www.keypedia.com/records/483/focalyx-technologies/ce74d0c3-70bf-47cd-a5a4-f893ed9b2fd9

> FDA 483 for Focalyx Technologies on December 01, 2025. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Focalyx Technologies
- Inspection Date: 2025-12-01
- Product Type: device
- Office Name: Florida District Office
- Summary: Focalx Technologies, LLC, a medical device manufacturer in Hialeah, FL, was cited for two significant observations during an FDA inspection. The firm failed to adequately verify and validate its Class II medical device software for compatibility with an upgraded operating system. Additionally, the company did not ensure its medical device labels bore a unique device identifier (UDI) and failed to submit required information to the Global Unique Device Identification Database (GUDID).

## Related Officers

- [Marvin A. Marenco](https://www.keypedia.com/people/marvin-a-marenco/b4638545-ba1f-4b1c-940f-7c18c5f436ed)

Company: https://www.keypedia.com/companies/focalyx-technologies/fe709d40-ab14-4517-92ea-5dd88985ab6a

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9