FDA 483 - Sunil Rangappa M.D. - August 01, 2022

Amicis Research Center, a clinical investigator site in Northridge, CA, was cited for failing to conduct an investigation in accordance with its investigational plan. The inspection revealed significant issues with missing and incomplete primary and efficacy assessment data for subjects in a clinical trial. This indicates a critical lapse in protocol adherence and data integrity for key study endpoints.