# FDA 483 - Resolution Biomedical Inc - December 12, 2019

Source: https://www.globalkeysolutions.net/records/483/resolution-biomedical-inc/44eecd5d-b40c-41a8-a0d5-f5645203cb98

> FDA 483 for Resolution Biomedical Inc on December 12, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Resolution Biomedical Inc
- Inspection Date: 2019-12-12
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Resolution Biomedical Inc, a medical device repackager in Tustin, CA, revealed significant deficiencies in their quality system. The firm failed to adequately establish and follow procedures for finished device acceptance, corrective and preventive actions, and purchasing controls. These issues indicate a systemic breakdown in maintaining quality standards for their repackaged medical devices.

## Related Documents

- [483 - 2025-11-19](https://www.globalkeysolutions.net/records/483/resolution-biomedical-inc/87e2d9c2-5e1c-4f96-99df-e562dbcea67e)

## Related Officers

- [Angelica G Aziz](https://www.globalkeysolutions.net/people/angelica-g-aziz/3aea89c9-72d6-4865-984e-936dd61d2786)

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

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