483
Medical Decision Network, LLCMedical Decision Network, LLC – FDA 483, May 25, 2021
Record Details
An FDA inspection of Medical Decision Network, LLC in Charlottesville, VA, identified a significant issue with document control procedures. The firm failed to adequately document process deviations, specifically lacking completion dates, communication, retraining, and monitoring requirements for all seven deviations reviewed since February 2019. This indicates a moderate severity issue related to quality system compliance.
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ID · b8d85043-48d1-4867-afd1-53bd6011327c
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