FDA EIR - Mitesh Borad, MD - October 24, 2017

An FDA inspection of Clinical Investigator Mitesh Borad, MD, operating out of Mayo Clinic Arizona in Scottsdale, was conducted over seven days from October 16-24, 2017. This was the first FDA inspection for Dr. Borad, and it was a comprehensive, for-cause evaluation under the Bioresearch Monitoring Compliance Program, focusing on Good Clinical Practices (GCPs) across two study protocols. The primary issue identified was a delay in reporting serious adverse events (SAEs) to the Institutional Review Board (IRB) for Protocol #(b)(4). The Clinical Investigator failed to respond to email notifications, which was required to complete the IRB's reporting and approval process for two reportable events involving subject deaths due to sepsis.

In response to this finding, the firm implemented a Corrective and Preventative Action Plan (CAPA). This plan included retraining staff on the SAE Reporting Standard Operating Procedure and submitting a revised informed consent form to the IRB to reflect new risks, though it was not used due to the study's closure. Despite these identified issues, the inspection concluded without the issuance of an FDA Form 483, Inspectional Observations, indicating that the concerns were addressed or did not warrant formal observations by the close-out meeting.