FDA EIR - Mehrnaz Hojjati MD - August 26, 2021

An FDA inspection of Dr. Mehrnaz Hojjati, M.D., a clinical investigator based in Loma Linda, CA, was conducted from August 23 to August 26, 2021. This "for cause" inspection, initiated by the Office of Scientific Investigations, CDER, adhered to the regulatory framework of CPGM 7348.811 for Bioresearch Monitoring Clinical Investigators and Sponsor-Investigators, referencing 21 CFR 312.60. The inspection's primary outcome was the issuance of an FDA Form 483, identifying a significant observation. The main violation concerned the investigation not being conducted in accordance with the signed statement of investigator and investigational plan. Specifically, five subjects were enrolled using an expired protocol (version 2) when an updated, proper version (version 3) was available. Furthermore, Subject 2 did not receive required urinalysis tests during two protocol-specified visits, with one deviation lacking proper, timely documentation. In response, Dr. Hojjati's management provided a Corrective Action Plan for the expired protocol issue and committed to submitting a comprehensive response addressing both identified deficiencies to the FDA within 15 business days. The final determination will be completed by the Center for Drug Evaluation and Research.