FDA 483 - IPAX, Incorporated - February 05, 2026

IPAX, Incorporated, a contract manufacturer in Englewood, CO, was cited for inadequate documentation of its risk management processes during the production of an adipose collection system. Specifically, the firm failed to document risks associated with a critical functional test and exhibited inconsistencies in the severity ranking of potential hazards within its Process Failure Mode and Effects Analysis (pFMEA). These issues indicate deficiencies in the firm's quality system regarding risk assessment and documentation.