FDA 483 - Bruce A. Segal, M.D. - December 18, 2025

An FDA inspection conducted at Bruce A. Segal, M.D., a clinical investigator facility, from December 8 to December 18, 2025, identified significant deviations from regulatory expectations. The inspection, carried out under the Federal Food, Drug, and Cosmetic Act, highlighted a failure to adhere to the investigational plan for a study. Specifically, the agency observed that an investigation was not conducted in accordance with its protocol. This included several critical issues: for four out of fifteen subjects, the incorrect study eye was selected; for two subjects, repeat intraocular pressure tests were not performed despite significant discrepancies in initial readings; and for one subject, a treatment prohibited by the protocol was prescribed for an adverse event without immediate discontinuation of the investigational product. These observations indicate a need for improved adherence to study protocols and proper investigation conduct to ensure data integrity and patient safety. Bruce A. Segal, M.D., is expected to evaluate these findings and implement comprehensive corrective actions to address the identified non-compliance and prevent recurrence, demonstrating a commitment to regulatory requirements and sound clinical practices.