FDA EIR - Mohammed Alhatou - June 16, 2016

An FDA inspection of Clinical Investigator Mohammed Alhatou, operating as The Neurology and Pain Clinic in Orangeburg, SC, was conducted from June 13-16, 2016. This OAI Follow-up Inspection, conducted under the CP7348.811 regulatory framework for Clinical Investigators, focused on the CI's conduct in a CDER-regulated study, "A Phase IIIb, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Alteplase in Patients with Mild Stroke" (PRISMS), sponsored by Genentech, Inc. The inspection reviewed the site's participation in this Phase IIIb clinical trial, which had enrolled only one subject. Crucially, the current inspection concluded with no significant objectionable conditions noted, and no FDA-483, Inspectional Observations, were issued. This outcome contrasts with a prior inspection (May-June 2014) which resulted in an FDA-483 and an OAI-untitled letter, citing violations like failure to follow the investigational plan, inadequate case histories, and insufficient record retention. The study under review had officially closed in December 2015. Although some protocol deviations, such as unlogged drug temperatures and incomplete assessments, were reported to the Institutional Review Board (IRB) during the study's operation, these did not lead to new FDA enforcement actions during this follow-up. As a result, no specific required actions were mandated from this inspection.