FDA 483 - 3D Smile USA Inc - March 29, 2024

An FDA inspection of 3D Smile USA Inc, a medical device manufacturer in New York, NY, revealed significant deficiencies in their quality system. The firm failed to maintain complaint files, adequately document corrective and preventive actions for multiple complaints, and ensure their Medical Device Reporting (MDR) procedures included device malfunctions as reportable events. These observations indicate a lack of robust controls for handling product complaints and adverse event reporting.