FDA EIR - Hessam Aazami, M.D. - February 04, 2020

An FDA surveillance inspection was conducted at Hessam Aazami, M.D.'s clinical site in Canoga Park, CA, beginning January 6, 2020, with the inspection report finalized by February 18, 2020. This high-priority inspection was performed under the New Drug Application regulatory framework and the Prescription Drug User Fee Act (PDUFA), aiming to verify data submitted in support of a requested drug indication, in accordance with Compliance Program 7348.810 for Clinical Investigators.The inspection revealed several significant observations, which were documented on a Form FDA 483. Key issues included the site's failure to provide 27 out of 31 electronic diary records for subjects, severely limiting the FDA's ability to assess adverse event reporting and determine primary study endpoints. Additionally, study staff documented inaccurate information in a subject's chart regarding a diagnosed infection, contrary to the Principal Investigator's clinical judgment. Concerns were also raised about the clinical and sub-investigators not updating financial interest information during or after the study, and the site's use of an electronic source data system without completing a required "Computerized Source Data Checklist." Furthermore, the site lacked electronic data for temperature recordings, excursions, or alert limits for test article storage, and no test article remained for inspection.These findings indicate deficiencies in record-keeping, data integrity, and protocol adherence, requiring the clinical investigator to implement corrective actions to comply with regulatory standards for clinical trials.