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

Source: https://www.keypedia.com/records/483/bio-rad-laboratories-inc/4d51c358-7af8-4096-99ee-58ac319c1c31

> 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: Division of Human and Animal Food Operations - West VI
- Summary: Bio-Rad Laboratories, Inc., an IVD manufacturer in Woodinville, WA, received a Form 483 observation during an FDA inspection. The firm was cited for deficiencies in its corrective and preventive action (CAPA) system. Specifically, the company failed to consistently establish and document risk assessments for quality issues, leading to inconsistent procedures and inadequate mitigation of identified risks.

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- [483 - 2025-01-31](https://www.keypedia.com/records/483/bio-rad-laboratories-inc/36343efa-7c4a-4197-83d5-855e16640377)

## 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/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822