FDA 483 - NEXALIN TECHNOLOGY INC. - March 10, 2023

NEXALIN TECHNOLOGY INC. in Houston, TX, a medical device specification developer, received a Form FDA 483 with eight observations during an inspection from February 14 to March 10, 2023. The inspection revealed significant deficiencies in their quality system, including repeat observations related to design control, CAPA procedures, and complaint investigations. These issues indicate a systemic lack of adherence to established quality practices for their Transcranial Electrotherapy Stimulator (TESA) medical devices.