FDA 483 - Scientific Analytics/DARI Motion, Overland Park, KS USA - August 26, 2021

An FDA inspection of DARI Motion, Inc. in Overland Park, KS, a manufacturer of the Class II DARI Health Interactive Rehabilitation Exercise system, revealed significant deficiencies across its quality management system. The firm failed to establish or adequately maintain fundamental procedures for design control, corrective and preventive actions, device master records, acceptance activities, complaint handling, quality audits, training, and management review. These widespread issues indicate a severe lack of compliance with medical device quality system regulations.