# FDA 483 - Resolution Biomedical Inc - November 19, 2025

Source: https://www.keypedia.com/records/483/resolution-biomedical-inc/b0c56707-7f76-46d6-86c1-2412f8808591

> FDA 483 for Resolution Biomedical Inc on November 19, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Resolution Biomedical Inc
- Inspection Date: 2025-11-19
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Resolution Biomedical Inc, a repackager in Tustin, CA, revealed significant quality system deficiencies. The firm was cited for inadequately established corrective and preventive action procedures, including insufficient investigations and effectiveness verification, which was a repeat observation. Additionally, personnel lacked necessary training for their job functions, and the firm failed to register its products, including a Class II device, in the Global Unique Device Identification Database (GUDID).

## Related Documents

- [483 - 2019-12-12](https://www.keypedia.com/records/483/resolution-biomedical-inc/44eecd5d-b40c-41a8-a0d5-f5645203cb98)
- [483 - 2025-11-19](https://www.keypedia.com/records/483/resolution-biomedical-inc/87e2d9c2-5e1c-4f96-99df-e562dbcea67e)

## Related Officers

- [Jordan I. Abel](https://www.keypedia.com/people/jordan-i-abel/9cdc8877-ab20-4c0c-a17e-a8534d4f13f2)
- [Tyler J. Chia](https://www.keypedia.com/people/tyler-j-chia/0f17c8f0-f7bc-4e5d-bbfa-a8bc7aa5dd66)

Company: https://www.keypedia.com/companies/resolution-biomedical-inc/1e90b1b6-4674-4f41-8cd3-acc727de527c

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6