FDA EIR - Nicola Longo, M.D., Ph.D. - January 13, 2014

An FDA inspection of Clinical Investigator Nicola Longo, M.D., Ph.D., in Salt Lake City, UT, was conducted from January 6 to January 13, 2014. This initial inspection, performed under the Bioresearch Monitoring Compliance Program for human drug studies, reviewed data from a sponsored clinical trial. While no formal FDA-483 was issued, the inspection identified several areas requiring attention, which were discussed with management. Key issues included inconsistent organization of study documents, specifically regarding the filing order of source materials within patient visit binders. There was a lack of standardized documentation for changes in recommended dosages, including rationale for performing or omitting certain analyses, and inconsistent reporting of blood chemistry units on lab printouts. Additionally, an expired Institutional Review Board (IRB) assent form was in use, and several FDA-1572 forms were signed on outdated versions. Dr. Longo and his team committed to implementing future corrections, such as formalizing documentation processes, ensuring consistent unit reporting for laboratory results, and promptly updating all expired regulatory forms to improve data accuracy, organizational consistency, and patient safety.