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