FDA 483 - Kendall South Medical Center, Inc. - October 27, 2025

An FDA inspection conducted from October 15 to October 27, 2025, at Mario A. Jimenez, M.D. Kendall South Medical Center, Inc. in Miami, FL, identified significant deficiencies in the conduct of a clinical investigation. The observations, documented on an FDA Form 483, highlight concerns regarding the clinical investigator's adherence to regulatory standards for clinical trials, primarily under the Federal Food, Drug, and Cosmetic Act.

The main violations centered on the failure to prepare or maintain adequate and accurate case histories. Specifically, the inspection revealed a lack of original and contemporaneous records to demonstrate proper randomization procedures following informed consent, with inadequate documentation noted for seven subjects. Discrepancies were found in concomitant medication records for nine subjects between source documents and the electronic data capture system. Furthermore, screening values for seventeen subjects were undocumented in source records despite being reported in the electronic system, and several subjects lacked proper documentation regarding exclusionary symptoms reported in their electronic diaries.

Additionally, the investigation was not conducted in accordance with the approved investigational plan, as one subject was randomized prematurely before the required period after informed consent. The facility is expected to address these findings by discussing objections or submitting a detailed plan for corrective actions to ensure compliance with clinical research protocols and record-keeping requirements.