# FDA 483 - Bio-Rad - March 07, 2023

Source: https://www.keypedia.com/records/483/bio-rad/4680bd26-3bac-49ee-8e47-18b79e63a1d0

> FDA 483 for Bio-Rad on March 07, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bio-Rad
- Inspection Date: 2023-03-07
- Product Type: biologics
- Office Name: International Compliance Team
- Summary: Bio-Rad in Steenvoorde, France, was cited for multiple deficiencies related to its manufacturing processes and quality system for biologic IVD and biologic substance products. Observations included unapproved production procedures, inadequate documentation of acceptance activities, and failures in corrective and preventive actions. The inspection also found issues with the use of expired materials and insufficient equipment calibration.

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Company: https://www.keypedia.com/companies/bio-rad/09f27a6e-2899-4555-99fe-fc72679b0922

Office: https://www.keypedia.com/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321