FDA 483 - Eugenia Girda, MD - October 18, 2022

An FDA inspection of Eugenia Girda, MD, a clinical investigator in New Brunswick, NJ, revealed a significant issue regarding the conduct of a clinical study. The investigator failed to report multiple adverse experiences for several subjects to the sponsor, which is a violation of the signed FDA 1572 Investigator Agreement. This indicates a serious lapse in adherence to clinical trial protocols and regulatory requirements.