FDA 483 - Glenn Gandelman, M.D. - March 10, 2023

An FDA inspection of Greenwich Cardiology Associates, Llc in Greenwich, CT, revealed significant deficiencies in the informed consent process for a clinical study. The firm failed to obtain proper informed consent from human subjects prior to conducting study-related tests and used unapproved consent forms. These issues indicate a lack of adherence to regulatory requirements for human subject protection.