FDA 483 - Scientific Analytics/DARI Motion, Overland Park, KS USA - November 10, 2022

DARI Motion, Inc., a manufacturer of Class II DARI Health Interactive Rehabilitation Exercise systems in Overland Park, KS, was cited with four observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's quality system, including inadequate procedures for acceptance activities, corrective and preventive actions, complaint handling, and supplier controls. Many of these issues were repeat observations from a previous inspection, indicating a persistent lack of compliance.