# FDA 483 - Bio-Rad Laboratories, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/bio-rad-laboratories-inc/eb6b2578-8b2d-4469-b37d-2816dd66445c

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

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## Details

- Record Type: 483
- Company Name: Bio-Rad Laboratories, Inc.
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of Bio-Rad Laboratories in Benicia, CA, identified two significant issues. The firm's procedures for corrective and preventive actions were found to be inadequately established, specifically regarding effectiveness check criteria. Additionally, the validation of device software was not adequately documented, with a lack of evidence showing actual results met expected results for a current software version.

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Company: https://www.keypedia.com/companies/bio-rad-laboratories-inc/38b660c0-864c-454c-be06-f003db64fb89

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b