FDA 483 - Cardiac Insight - February 07, 2025

Cardiac Insight, Inc. in Bellevue, WA, received a Form 483 citing two observations related to its quality system for the Class II Cardea SOLO device. The firm failed to adequately document corrective and preventive action (CAPA) activities and results, and its procedures for receiving, reviewing, and evaluating complaints were not adequately established, leading to untimely processing. These issues indicate a need for improved adherence to established quality system regulations.