FDA EIR - Doris V. Quon, M.D. - August 03, 2020

An FDA routine PDUFA inspection of clinical investigator Doris Voy Kan Quon, M.D., Ph.D., at Los Angeles, CA, was conducted from July 28 to August 3, 2020. This inspection fell under Compliance Program 7348.811, governing Clinical Investigators and Sponsors-Investigators, and was regulated by §505 of the Federal Food, Drug, and Cosmetic Act. The inspection covered Protocol Number (b) (4), focusing on IRB approvals, financial disclosures, training records, informed consent forms, and subject records for three enrolled participants. Crucially, no FDA 483, Inspectional Observations, was issued to the site at the inspection's conclusion, indicating no significant violations. The primary discussion point involved an observation during a review of subject (b) (6)'s Day 1 records, noting several concomitant medications that were not initially included in the data line listings. Dr. Quon acknowledged her ultimate responsibility as Clinical Investigator for reviewing all records, clarified the situation, and committed to ensuring all current medications would be accurately recorded in the eCRFs. The site demonstrated overall adherence to the protocol and accurate data reporting, suggesting a favorable outcome.