FDA 483 - Orchestrate Orthodontic Technologies, Inc. - October 28, 2021

An FDA inspection of Orchestrate Orthodontic Technologies, Inc. in Rialto, California, a medical device specification developer, revealed two significant observations. The firm distributed an unapproved version of its Orchestrate 3D Directions for Use (DFU) lacking essential information and proper control numbers. Additionally, records for customer complaint investigations for their Orchestrate 3D Software were found to be incomplete, missing crucial complainant details and software version information.