FDA 483 - NEUROLOGICAL FITNESS EQUIPMENT and EDUCATION LLC, dba NEUFIT - September 29, 2021

An FDA inspection of NEUROLOGICAL FITNESS EQUIPMENT AND EDUCATION LLC (NEUFIT) in Austin, TX, revealed significant deficiencies in their quality system for medical devices. The firm failed to adequately establish and implement procedures for complaint handling, corrective and preventive actions, incoming product acceptance, supplier evaluation, and servicing activities. These issues indicate a broad lack of control over critical aspects of medical device quality and safety.