FDA 483 - Beasley E. Robert, MD - July 21, 2025

Robert E. Beasley, MD, a clinical investigator in Fort Lauderdale, FL, received a Form 483 for failing to conduct an investigation according to its investigational plan. The primary finding involved significant and extensive delays in reporting serious adverse events (SAEs) to the sponsor for multiple subjects in a clinical trial. These delays, some lasting hundreds of days, indicate a serious lapse in patient safety monitoring and regulatory compliance.