Cardiva Medical, Inc. – FDA 483, Jul 21, 2023

An FDA inspection of Cardiva Medical, Inc. in Santa Clara, CA, identified four significant quality system deficiencies. These included inadequate procedures for management review, incomplete documentation for complaint investigations, insufficient documentation of corrective and preventive actions (CAPA) and their effectiveness, and undocumented personnel training effectiveness. The findings highlight systemic issues in maintaining a robust quality management system.