483
Stephen G. Thein, Ph.D.FDA 483 - Stephen G. Thein, Ph.D. - April 25, 2025
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Record Details
Pacific Research Network (PRN) in San Diego, a clinical investigator, was cited for failing to conduct an investigation in accordance with its investigational plan. Specifically, participants who tested positive for cannabinoids were allowed to continue in a study without termination or proper reporting. Additionally, the firm implemented changes in research activity without prior Institutional Review Board (IRB) approval.
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ID · ebf5447b-fa2c-4b23-ba5c-e9211916f398