FDA 483 - Bruce A. Segal, M.D. - December 18, 2025
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An FDA inspection of Bruce A. Segal, M.D. in Delray Beach, FL, a clinical investigator, revealed significant deviations from an investigational plan. The firm failed to adhere to protocol requirements for study procedures, including selecting incorrect study eyes, not performing required intraocular pressure tests, and prescribing a prohibited treatment without timely discontinuation of investigational product. These findings indicate a lack of adherence to study protocols during clinical investigations.
ID · 5e1f9c84-dc22-4432-810c-14dc08b9669c