483
HeartStitch, Inc.HeartStitch, Inc. – FDA 483, Jun 25, 2025
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.
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ID · 7adba76d-cffa-4769-92a2-44b8837a6db3
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