FDA 483 - BioSculptor Corporation - October 19, 2022

An FDA inspection of BioSculptor Corporation in Hialeah, FL, a medical device manufacturer of the kinderBAND™ cranial orthosis helmet, revealed significant deficiencies in their quality system. The inspection cited repeat observations regarding inadequate equipment calibration procedures and untrained personnel conducting quality audits. Additional issues included failures to maintain device history records and establish adequate supplier management processes.