# FDA 483 - Bio-Rad Laboratories, Inc. - January 31, 2025

Source: https://www.keypedia.com/records/483/bio-rad-laboratories-inc/36343efa-7c4a-4197-83d5-855e16640377

> FDA 483 for Bio-Rad Laboratories, Inc. on January 31, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bio-Rad Laboratories, Inc.
- Inspection Date: 2025-01-31
- Product Type: device
- Office Name: Seattle District Office
- Summary: Bio-Rad Laboratories, Inc. in Woodinville, WA, an IVD manufacturer, was issued a Form 483 following an inspection that identified significant deficiencies in its quality system. The firm failed to consistently establish and document risk assessments across its corrective and preventive action (CAPA) procedures. This included inconsistent risk definitions and a lack of documented risk identification and mitigation for several CAPAs.

## Related Documents

- [483 - 2019-10-21](https://www.keypedia.com/records/483/bio-rad-laboratories-inc/8cbbd2f7-b9fd-4d0c-ae12-b39199310a80)
- [483 - 2021-12-13](https://www.keypedia.com/records/483/bio-rad-laboratories-inc/23c046ed-1013-40ed-9ca9-97d618941c5c)

## Related Officers

- [investigator](https://www.keypedia.com/people/kaarin-m-slotte/2960bbe1-17ba-4295-9aa8-2514a1595336)
- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)

Company: https://www.keypedia.com/companies/bio-rad-laboratories-inc/b3fd776e-6823-4ba3-87b0-f03cf4880139

Office: https://www.keypedia.com/offices/seattle-district-office/9305837f-0738-4075-b444-a55e7a2b8913