IPAX, Incorporated – FDA 483, Feb 5, 2026

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.