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

Source: https://www.keypedia.com/records/483/resolution-biomedical-inc/87e2d9c2-5e1c-4f96-99df-e562dbcea67e

> 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: Los Angeles District Office
- Summary: Resolution Biomedical Inc. in Tustin, CA, a repackager, was inspected by the FDA and received a Form 483 with three observations. The inspection revealed significant deficiencies in corrective and preventive action procedures, inadequate personnel training, and a failure to register unique device identifier information in the GUDID. These issues indicate a lack of robust quality system controls, with one observation being a repeat from a previous inspection.

## Related Documents

- [483 - 2019-12-12](https://www.keypedia.com/records/483/resolution-biomedical-inc/44eecd5d-b40c-41a8-a0d5-f5645203cb98)

## Related Officers

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

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

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