FDA 483 - Dennis J. Hsu, M.D - March 03, 2026

During an inspection of the clinical research site of Dennis J. Hsu, M.D., located at the UPMC Hillman Cancer Center in Pittsburgh, Pennsylvania, the Food and Drug Administration (FDA) identified a failure to comply with established clinical study protocols. The inspection occurred on various dates between February 10, 2026, and March 3, 2026. The primary violation involved the failure to adhere to the signed investigator statement and specific reporting requirements for serious adverse events (SAEs). Specifically, the study protocol required that any Grade 3 serious adverse event be reported to the National Cancer Institute via the CTEP-AERS system within ten calendar days of the site becoming aware of the situation. The FDA investigator found that for one subject who experienced an SAE in late August 2022, the site was notified on September 13, 2022, yet the formal report was not submitted until November 30, 2022. This delay represents a significant departure from the trial"s safety monitoring guidelines. This inspection was conducted under Section 704(b) of the Federal Food, Drug, and Cosmetic Act. While the Form 483 represents preliminary findings rather than a final agency determination, the clinical investigator is expected to provide a written response. This response should include a plan for corrective actions to address the reporting deficiency and ensure future compliance with safety protocols.