FDA 483 - Santiago Ortega Gutierrez, M.D. - January 17, 2025

An FDA inspection conducted at Santiago Ortega Gutierrez, M.D., from January 13-17, 2025, identified two significant observations related to clinical trial conduct. The primary finding was the inaccuracy of subject case history records. For multiple subjects, incorrect measurement data from source documents were repeatedly transferred to the electronic Case Report Form (eCRF) and Electronic Data Capture (EDC) system. These inaccuracies, including miscalculated ratios, were not corrected and persisted through several data reviews, indicating a lapse in data integrity and quality control.

The second observation noted that the investigation was not conducted in adherence to the investigational plan. Specifically, Serious Adverse Events (SAEs) for two subjects were not reported to the sponsor within the required 24-hour timeframe, as mandated by the clinical trial protocol. These events were recorded days or weeks after the study staff became aware of them, delaying critical safety reporting.

These observations indicate deficiencies in adhering to regulatory expectations for clinical investigations, particularly regarding accurate record-keeping and timely adverse event reporting. The firm is expected to address these objectionable conditions by evaluating the root causes and implementing appropriate corrective and preventive actions to ensure compliance with applicable regulations.