FDA 483 - IPAX, Incorporated - February 05, 2026
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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.
ID · c2420ef2-e0ef-43e2-9302-6adfd264b22d