FDA EIR - Han C. Phan, M.D. - April 05, 2024

A surveillance inspection of Han C. Phan, M.D., a Clinical Investigator, was conducted by the FDA from April 1 to April 5, 2024. Operating under the regulatory framework for Clinical Investigators (CP 7348.811), the inspection identified several critical issues, resulting in the issuance of an FDA Form 483. The main violation centered on the failure to retain complete source records for a clinical study, including discrepancies between collected data and background materials, and missing off-site paper questionnaires. Additional concerns included assessors not adhering to established scoring rules for primary efficacy endpoints, and paper screening records lacking proper identification of the assessor or containing pencil entries. Dr. Phan committed to submitting a written response to the FDA Form 483 within 15 business days. Required actions include acquiring all missing source records, obtaining certified copies of electronic records and associated audit trails from the sponsor or service provider, and ensuring that future paper records are properly attributed and completed without pencil entries. Dr. Phan also stated that an individual responsible for incorrect scoring had been removed from the study. The inspection was classified as "Correction Indicated" pending final agency review.