FDA 483 - Nancy Navarro Gonzalez, M.D. - July 01, 2025

An FDA inspection of San Marcus Research Clinic, Inc. in Miami Lakes, FL, revealed significant deficiencies in maintaining accurate, complete, and current subject case history records. For 7 out of 24 reviewed subject records, study data in source documentation was found to be incomplete, inaccurate, not contemporaneous, and inconsistent with the Electronic Data Capture system. These issues indicate serious concerns regarding data integrity and compliance with clinical trial regulations.