HeartStitch, Inc.June 25, 2025

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

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Record Details

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.

Company: HeartStitch, Inc.
Inspection Date: June 25, 2025
Product Type: Other
Office: Los Angeles District Office
Person: Jordan I. Abel

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ID · 7adba76d-cffa-4769-92a2-44b8837a6db3