FDA EIR - John D. Gabriel, MD - February 18, 2016

An FDA inspection of John Gabriel, MD, operating as North Hills Medical Research, Inc., was conducted from February 1 to February 18, 2016. This high-priority inspection, performed under Compliance Program 7348.811, aimed to validate data and assess compliance with FDA regulations governing clinical studies, specifically those involving investigational new drugs.The inspection resulted in an Official Action Indicated (OAI) classification and the issuance of a one-item Form FDA-483, Inspectional Observations, citing a failure to conduct the investigation in accordance with the signed investigator statement and investigational plan, as required by 21 CFR 312.60.Key violations included the randomization of 26 out of 35 subjects to study medication before obtaining necessary serum creatinine lab values, leading to 9 subjects being overdosed. Additionally, required dose adjustments for reduced renal function were not performed for some subjects, and critical inclusion/exclusion criteria were not consistently met. This involved a lack of source documentation for qualifying lab values from point-of-care devices for 26 subjects and enrolling a subject on exclusionary medication. Furthermore, records detailing the cause of death for two subjects were missing, and one primary efficacy endpoint was not accurately reported in data listings.These findings indicate a significant deviation from protocol and regulatory requirements, necessitating a comprehensive response and corrective actions from the firm to ensure future compliance and data integrity.