FDA 483 - Unknown Company - September 16, 2025

Between September 2 and September 16, 2025, the U.S. Food and Drug Administration (FDA) conducted an inspection of the facility of Clinical Investigator Lan Luo, M.D., operating as Ocala Cardiovascular Research in Ocala, Florida. The inspection revealed several significant violations of the Federal Food, Drug, and Cosmetic Act regarding the management of clinical trial protocols. Key issues identified during the inspection included a failure to follow the established investigational plan, leading to incorrect subject randomization and the administration of the wrong investigational products. The site also failed to confirm participant eligibility through mandatory laboratory testing prior to enrollment. Furthermore, the investigator demonstrated inadequate oversight of drug accountability, with missing supplies and incomplete records of medication dispensed to and returned by subjects. Significant delays and omissions were also noted in reporting safety events to study sponsors, with some adverse events remaining unreported or entered into systems years after their occurrence. Finally, case histories and visit records were found to be inaccurate, incomplete, and lacked proper signatures. This document serves as a report of preliminary observations. Dr. Luo is expected to provide a written response to the FDA detailing the corrective actions taken or planned to address these deficiencies. Failure to rectify these issues may result in further regulatory intervention.