FDA EIR - Animesh Pardanani - March 08, 2019

An FDA inspection of Clinical Investigator Animesh Pardanani, M.B.B.S., Ph.D., located at Mayo Clinic, was conducted from March 4-8, 2019. This high-priority surveillance inspection, conducted under Compliance Program 7348.811, focused on Dr. Pardanani's adherence to clinical trial protocols, informed consent, data practices, and regulatory reporting requirements for a drug study supporting an NDA. The inspection identified significant deficiencies, resulting in a 3-item FDA Form 483. Key violations, citing 21 CFR 312.66, included the failure to promptly report an unanticipated problem involving risk to human subjects (UPIRTSO) to the Institutional Review Board (IRB) within the required five business days. Furthermore, the investigator did not ensure proper continuing review by the IRB, as non-UPIRTSO serious adverse events, non-serious adverse events, subject withdrawals, consented screen failures, and numerous protocol deviations were not submitted as mandated. The inspection also noted late reporting of three serious adverse events to the study sponsor, exceeding the protocol's one-working-day requirement. Dr. Pardanani acknowledged all observations, expressed an intent to double efforts to prevent recurrence, and committed to submitting a comprehensive response with corrective actions to the FDA within 15 business days.