# FDA 483 - IPAX, Incorporated - February 05, 2026

Source: https://www.globalkeysolutions.net/records/483/ipax-incorporated/c2420ef2-e0ef-43e2-9302-6adfd264b22d

> FDA 483 for IPAX, Incorporated on February 05, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: IPAX, Incorporated
- Inspection Date: 2026-02-05
- Product Type: device
- Office Name: Denver District Office
- Summary: An FDA inspection of IPAX, Incorporated in Englewood, CO, from February 3-5, 2026, revealed deficiencies in the firm's risk management processes for product realization. Specifically, the company failed to adequately document risks associated with a functional test for an adipose collection system and exhibited inconsistencies in severity rankings within their process FMEA for potential hazards like vacuum loss. These issues indicate a need for improved documentation and clarity in their quality system.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/matthew-m-vernon/f77e8c18-8614-49e3-9b19-3327b7fe7648)

Company: https://www.globalkeysolutions.net/companies/ipax-incorporated/348a717b-4dba-4cb6-8781-82a8917ab9fe

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face