# FDA 483 - Koya Medical, Inc - October 24, 2025

Source: https://www.keypedia.com/records/483/koya-medical-inc/72f3f7bb-af4c-4945-a974-41b2f7708883

> FDA 483 for Koya Medical, Inc on October 24, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Koya Medical, Inc
- Inspection Date: 2025-10-24
- Product Type: device
- Office Name: Dallas District Office
- Summary: Koya Medical, Inc. in Dallas, TX, was cited for inadequate procedures for receiving, reviewing, and evaluating complaints. The firm failed to properly assess the reportability of adverse events, including electric shocks and burns, which may be Medical Device Report (MDR) reportable. The evaluation process lacked necessary assessments and contradicted its own risk management definitions for serious injuries.

## Related Officers

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

Company: https://www.keypedia.com/companies/koya-medical-inc/946d648a-9b96-43b9-b8ee-2f88671fc4a6

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9