FDA 483 - Apex Medical Technologies, Inc. - January 15, 2026

An FDA inspection of Apex Medical Technologies, Inc. in San Diego, CA, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for handling customer complaints, including UDI documentation and investigation rationale. Additionally, their corrective and preventive action (CAPA) procedures were found to be inadequate, specifically regarding root cause analysis, documentation of corrective actions, and verification of effectiveness.