483
Bio-Rad Laboratories, Inc.FDA 483 - Bio-Rad Laboratories, Inc.
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Record Details
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.
- Company
- Bio-Rad Laboratories, Inc.
- Product Type
- Device
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ID · eb6b2578-8b2d-4469-b37d-2816dd66445c