FDA 483 - NEUROLOGICAL FITNESS EQUIPMENT and EDUCATION LLC, dba NEUFIT - July 03, 2024

An FDA inspection of NEUROLOGICAL FITNESS EQUIPMENT AND EDUCATION LLC, dba NEUFIT, in Austin, TX, revealed significant deficiencies in its complaint handling system. The firm failed to promptly review, evaluate, and investigate MDR-reportable complaints, with critical documentation lacking required signatures. Additionally, procedures for receiving, reviewing, and evaluating complaints were not adequately established, leading to insufficient documentation of oral complaints, MDR reportability evaluations, and investigative actions.