FDA 483 - HeartStitch, Inc. - June 25, 2025

HeartStitch, Inc. in Fountain Valley, CA, underwent an FDA inspection from June 20-25, 2025. The inspection identified a deficiency in the firm's corrective and preventive action (CAPA) system. Specifically, the firm failed to adequately document the effectiveness verification for completed CAPAs, indicating a lapse in quality system compliance.