Han C. Phan, M.D. – FDA Warning Letter, Apr 5, 2024

The FDA issued a Warning Letter to Dr. Phan following an inspection of their clinical site from April 1-5, 2024, concerning the conduct of a clinical investigation (Protocol (b)(4)). The inspection, part of the Bioresearch Monitoring Program, revealed non-adherence to the Federal Food, Drug, and Cosmetic Act and 21 CFR Part 312 governing clinical investigations. Key violations include the failure to ensure the investigation was conducted according to the investigational plan (21 CFR 312.60). Specifically, site assessors inconsistently and incorrectly applied clinical outcome assessments (COAs), testing subjects beyond established requirements, and procedures for establishing (b)(4) for assessments were not followed, leading to inconsistent establishment. This raises significant concerns about the interpretability, validity, and integrity of the study data, particularly for a primary efficacy endpoint. The FDA noted inadequate and inconsistent documentation, a lack of retraining for site assessors, and no apparent corrective or preventive actions despite the findings being discussed during the inspection. Dr. Phan is required to notify the FDA in writing within 15 business days of receipt of the letter, detailing actions taken to prevent similar violations, as failure to adequately address these issues may lead to regulatory action.