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

Source: https://www.keypedia.com/records/483/heartstitch-inc/7adba76d-cffa-4769-92a2-44b8837a6db3

> FDA 483 for HeartStitch, Inc. on June 25, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: HeartStitch, Inc.
- Inspection Date: 2025-06-25
- Product Type: other
- Office Name: Los Angeles District Office
- Summary: 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.

## Related Officers

- [Jordan I. Abel](https://www.keypedia.com/people/jordan-i-abel/9cdc8877-ab20-4c0c-a17e-a8534d4f13f2)

Company: https://www.keypedia.com/companies/heartstitch-inc/c4b688fa-d6bd-4b35-9c6f-ded4a89407ad

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b