FDA 483 - Vivos Therapeutics Inc. - October 24, 2024

An FDA inspection of Vivos Therapeutics Inc. in Murray, KY, revealed deficiencies in their complaint handling procedures. The firm's complaint records were found to inconsistently include required device identification (UDI/UPC) and lacked adequate documentation to support root cause determinations. These issues indicate a need for improvement in their quality system for managing complaints.