FDA 483 - NEXALIN TECHNOLOGY INC. - February 20, 2020

NEXALIN TECHNOLOGY INC. in Houston, TX, a specification developer for a Class 3 transcranial electrotherapy stimulator (TESA), was inspected and found to have significant quality system deficiencies. The firm failed to maintain a device master record, establish adequate design control procedures, and properly document or implement corrective and preventive actions. Additionally, procedures for handling and evaluating customer complaints were not established, indicating a broad lack of adherence to quality system requirements.