# FDA 483 - Bio-Rad Laboratories, Inc. - December 13, 2021

Source: https://www.keypedia.com/records/483/bio-rad-laboratories-inc/23c046ed-1013-40ed-9ca9-97d618941c5c

> FDA 483 for Bio-Rad Laboratories, Inc. on December 13, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bio-Rad Laboratories, Inc.
- Inspection Date: 2021-12-13
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Bio-Rad Laboratories, Inc. in Woodinville, WA, a licensed in-vitro diagnostic manufacturer, was cited for two significant issues during an FDA inspection. The firm failed to adequately document corrective and preventive action activities, specifically regarding nonconformance reports for an HIV-1 Western Blot Kit. Additionally, document control procedures for batch and quality control records were not properly established and maintained.

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## Related Officers

- [Program Expert for Advanced Manufacturing ](https://www.keypedia.com/people/prabhu-p-raju/2c0aaede-fe16-4431-bc21-614d7f18cb32)
- [Lewis K. Antwi](https://www.keypedia.com/people/lewis-k-antwi/8ab4f1c7-8b5b-4556-98a4-6edc3bc49470)

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