FDA 483 - VITANG TECHNOLOGY LLC - January 31, 2023

VITANG TECHNOLOGY LLC, a manufacturer and specification developer of UniSmile Clear Aligners in Tustin, CA, was cited for numerous significant quality system deficiencies. The inspection revealed issues across design control, software validation, complaint handling, supplier management, equipment qualification and calibration, device history records, quality audits, management reviews, and personnel training. These observations indicate a broad lack of established and followed procedures essential for medical device manufacturing.