FDA 483 - Nielsen Biosciences, Inc - April 17, 2025
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Nielsen Biosciences, Inc. in San Diego, CA, a licensed biological drug manufacturer, was inspected and cited for multiple deficiencies in its quality system. Key issues include failures in maintaining adequate records for annual product reviews, significant delays in closing and initiating deviations and CAPAs, and a lack of thorough investigation into unexplained discrepancies. Additionally, the firm was found to have inadequate qualified personnel for critical testing and lacked established procedures for reporting biological product deviations.
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