FDA 483 - David Pham, M.D. - June 18, 2025
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Allianz Research Institute Co in Aurora, CO, was cited for significant deficiencies in clinical trial conduct during an FDA inspection. Observations included failures in adhering to investigator statements, obtaining proper informed consent, maintaining accurate case histories, and promptly reporting unanticipated problems to the IRB. The firm also had issues with investigational drug accountability, indicating a broad lack of oversight in their clinical research operations.
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