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

An FDA inspection of San Marcus Research Clinic, Inc. in Miami Lakes, FL, revealed critical deficiencies in record-keeping practices. For 7 out of 24 reviewed subject records, study data in source documentation was incomplete, inaccurate, not contemporaneous, and did not match the Electronic Data Capture (EDC) system, indicating severe data integrity issues.