FDA 483 - Mario A. Jimenez, M.D. - October 27, 2025

Kendall South Medical Center, Inc. in Miami, FL, a clinical investigator, was cited for significant deficiencies in maintaining adequate and accurate case histories and for not conducting an investigation in accordance with the investigational plan. The inspection revealed multiple instances of missing or discrepant documentation for subject randomization, concomitant medications, and screening values, as well as failures to follow protocol requirements for subject randomization. These issues indicate a lack of robust data integrity and adherence to study protocols during clinical trials.