FDA 483 - BRAINCHECK, INC. - September 18, 2025

An FDA inspection of BRAINCHECK, INC. in Austin, TX, from September 15-18, 2025, revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures. The company failed to adequately establish procedures for disseminating information on quality problems and lacked consistent documentation to verify the effectiveness of CAPA actions. These findings indicate a need for improved quality system controls.