FDA 483 - Brian S. Biesman, M.D. - October 14, 2025

An FDA inspection conducted at Brian S. Biesman, MD, from October 6-14, 2025, identified a significant observation detailed in an FDA 483 report. The primary issue cited was that a clinical investigation was not conducted in accordance with its approved investigational plan. Specifically, the inspection revealed that 15 out of 37 enrolled subjects failed to meet essential eligibility criteria outlined in the protocol. Detailed findings included instances where three subjects received investigational product before critical screening laboratory results were returned, and twelve others were dosed despite having missing screening clinical laboratory evaluations. Additionally, four subjects were dosed without required specific screening tests. Further non-compliance involved one subject randomized and dosed with non-matching investigator and subject scores at screening, another deemed ineligible for an evaluation due to an incorrect severity score at Day 43 but still dosed, and one subject dosed despite a missing required test at Day 43. These observations indicate a failure to strictly adhere to the study protocol for subject eligibility, impacting the integrity of the clinical investigation. This FDA 483 document serves as an initial report under Section 704(b) of the Federal Food, Drug and Cosmetic Act, and the firm is expected to discuss or submit corrective actions to address these findings and ensure future compliance with regulatory standards for clinical investigations.