FDA EIR - Sanofi US Services, Inc. - October 09, 2018

A routine surveillance inspection of Sanofi-Aventis U.S. LLC in Bridgewater, NJ, was conducted by the FDA from September 26 to October 9, 2018. The inspection, carried out under the Sponsor, Contract Research Organizations, and Monitor Compliance Program (CP) 7348.810, aimed to assess the firm's compliance with applicable regulations. The review focused on the conduct of a randomized, double-blind, placebo-controlled clinical study involving Alirocumab for cardiovascular events. The FDA investigator examined various operational aspects, including training programs, Standard Operating Procedures, vendor and site selection processes, monitoring activities, and adverse event reporting procedures. A significant finding of this inspection was that no Form FDA-483, Inspectional Observations, was issued at its conclusion. This indicates that no main violations or significant deficiencies were identified by the FDA. Discussions included the firm's management of subjects from a terminated clinical site using a call center and adjustments to Suspected Unexpected Serious Adverse Reaction (SUSAR) reporting, but these processes were deemed adequately handled. Consequently, no specific required actions were mandated by the FDA, signifying that Sanofi-Aventis U.S. LLC was found to be in compliance with the relevant regulatory framework during this inspection.