FDA 483 - Ignacio J. Rodriguez, MD - September 29, 2020

An FDA inspection of Ignacio J. Rodriguez, MD, a clinical investigator in Hialeah, FL, revealed significant non-compliance with the investigational plan. The firm randomized subjects who met exclusion criteria or failed to meet randomization criteria, did not promptly report Serious Adverse Events to the sponsor, and administered investigational product without confirming continuing eligibility. These findings indicate a failure to adhere to study protocols and regulatory requirements for clinical trials.