FDA 483 - Vivos Therapeutics, Inc. - August 27, 2020

Vivos Therapeutics, Inc. in Highlands Ranch, CO, a medical device manufacturer, was cited for significant deficiencies during an FDA inspection. The firm's design history file for its Vivos mRNA appliance® lacked required documentation and components, failing to demonstrate proper design control. Additionally, procedures for corrective and preventive actions (CAPA) were inadequately established and documented, leading to objectionable conditions in reviewed CAPA records.