FDA 483 - Muhammad M. Salim, MD - October 23, 2025
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An FDA inspection of Chandler Clinical Trials/Elite Clinical Network in Chandler, AZ, revealed significant failures in maintaining adequate and accurate case histories for human clinical studies of investigational drugs. The report details numerous discrepancies in subject records, including issues with informed consent, laboratory reports, physician's orders, and adverse event documentation. These findings indicate serious deficiencies in data integrity and record-keeping practices during clinical trials.
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