FDA EIR - Guillermo Valenzuela, MD - February 09, 2017

An FDA inspection of Guillermo Valenzuela, M.D., a Clinical Investigator located in Plantation, FL, was conducted from January 30 to February 9, 2017. This was an initial, comprehensive, user-fee based inspection, requested by the Center for Drug Evaluation and Research (CDER) to assess a specific premarket Biologics License Application (BLA) clinical study. The inspection sought to ensure compliance with FDA regulations governing clinical investigations. The review encompassed several critical areas including study administration, protocol adherence, Institutional Review Board (IRB) approvals, subject informed consent, source data integrity, financial disclosures, electronic record management, and control of investigational products. Documentation for enrolled subjects, adverse event reporting, and staff training were also thoroughly assessed. Crucially, the inspection concluded with no significant deficiencies observed, and no Form FDA-483, Inspectional Observations, was issued to Dr. Valenzuela. The report noted proper reporting of all Serious Adverse Events, adequate training of study staff, and well-organized, legible records. Dr. Valenzuela and his team fully cooperated during the process. While no specific violations or required corrective actions were identified, Dr. Valenzuela was reminded of his continuing obligation to adhere to all applicable FDA regulations for clinical research.