FDA 483 - Lazzaro, Marc, MD - March 23, 2015

Froedtert Memorial Lutheran Hospital was cited for significant non-compliance during an inspection of its investigational studies. Observations included enrolling subjects who met exclusion criteria, failing to accurately and timely report deviations to the IRB, and issues with obtaining and documenting informed consent. Additionally, the Principal Investigator failed to ensure the accuracy and completeness of subject records and case report forms.