Opada Alzohaili, M.D. – FDA EIR, Mar 29, 2016

This FDA follow-up inspection of Opada Alzohaili, M.D., conducted from March 8-29, 2016, in Dearborn, MI, was a high-priority, for-cause Official Action Indicated (OAI) review. The inspection aimed to verify corrective actions taken in response to a 2014 Warning Letter and ensure ongoing compliance with FDA regulatory requirements, including 21 CFR 50.27(a) and 21 CFR 312.62(b) under the Bioresearch Monitoring Compliance Program 7348.811.

The 2014 Warning Letter cited failures in protecting subject rights, adhering to investigational plans, and maintaining adequate case histories. The current inspection reviewed two studies, EFC12404 and CP-4-005, focusing on subject eligibility, investigational product usage, protocol adherence, and informed consent.

The 2016 inspection identified two main violations, documented on an FDA Form 483: a) failure to ensure informed consent documents were dated by the subject, and b) inadequate and inaccurate case histories, specifically concerning conflicting medical record information related to subject eligibility and medication use. The investigator attributed some discrepancies to electronic medical record system issues.

Dr. Alzohaili committed to providing a written response to these observations. In response to previous findings, several voluntary corrective actions were implemented, including a two-step verification process for study drug dispensing, enhanced informed consent training, a three-step data integrity verification process, regular staff meetings, and the development of a Standard Operating Procedure (SOP) for clinical research activities. The Institutional Review Board (IRB) had previously suspended and later lifted an enrollment suspension for one study after the investigator addressed the cited issues. Dr. Alzohaili decided to cease participating in clinical research in 2015.