FDA 483 - Advanced Facialdontics LLC - July 22, 2022

Advanced Facialdontics LLC, a medical device manufacturer in East Islip, NY, received four observations during an FDA inspection. The firm was cited for significant deficiencies in its quality system, including the failure to establish a complete design history file, lack of formally approved quality system procedures for various critical activities, and an inadequate risk analysis for its POD mouth guard device. Additionally, the firm had not developed written Medical Device Reporting (MDR) procedures, indicating a broad lack of control over device design, manufacturing, and post-market surveillance.