Mark A. Hernandez, M.D. – FDA EIR, Sep 11, 2020

An FDA inspection of Mark Hernandez, M.D. was conducted from August 31 to September 11, 2020. This PDUFA, NDA inspection for a Clinical Investigator was performed under Compliance Program 7348.811, focusing on bioresearch monitoring. The inspection assessed various aspects of a drug protocol, including trial administration, protocols, IRB processes, subject informed consents, investigational product control, and data integrity. While no FDA Form 483 (Inspectional Observations) was issued, several significant issues were discussed during the closing meeting. These included 13 subjects lacking original source documents for visits, 6 subjects missing specific paper source records, and one subject without an updated screening printout. Critically, one subject continued receiving investigational product after withdrawing consent, and another's repeated lab analysis was not followed up despite the sample never reaching the lab. Five subjects also presented minor administrative discrepancies in their records. Additionally, it was noted that original paper source for an electronic rating scale was discarded after digital upload. In response, Dr. Hernandez proposed voluntary corrections, which involved ensuring all original source documents are collected and maintained, verifying updated screening printouts, implementing measures to prevent subjects from continuing investigational product after withdrawing consent, and ensuring proper follow-up on outstanding lab analyses. The site committed to retaining all original source documents for electronic rating scales if received. The inspection concluded without formal observations.