FDA 483 - Idalia Acosta, M.D. - January 16, 2025

The FDA inspected San Marcus Research Clinic, Inc. in Miami Lakes, FL, as a clinical investigator, revealing significant deficiencies in maintaining adequate and accurate case histories. The inspection found multiple instances of data discrepancies, including conflicting screening weights, inconsistent investigational product accountability, and missing or duplicated source documentation for study subjects. These observations highlight serious concerns regarding the integrity and reliability of clinical trial data at the facility.