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

An FDA inspection of Dr. Marc Lazzaro, Principal Investigator at Froedtert Memorial Lutheran Hospital (Milwaukee, WI), was conducted from February 24 to March 23, 2015. This early intervention inspection, prompted by an Institutional Review Board (IRB) notification of “Serious and Continuing Non-Compliance” in device studies, identified significant deviations from regulatory requirements and approved protocols. The inspection, conducted under Compliance Program 7348.811 for clinical investigators, resulted in a four-item FDA-483, detailing inspectional observations. Key violations included the enrollment of subjects who met exclusion criteria in two investigated device trials, compromising participant safety and data integrity. Furthermore, required reporting to the IRB was either not performed or significantly delayed, preventing timely oversight. Records documenting informed consent were found to be inaccurate, incomplete, or not current, including instances of signatures being altered or assessments conducted before consent was obtained. Critically, the Principal Investigator, Dr. Lazzaro, demonstrated insufficient oversight of the study's conduct and maintenance of study files. These issues indicated a systemic failure in adhering to good clinical practices and relevant FDA regulations (e.g., 21 CFR 812.110(b), 21 CFR 812.140(a)(1), 21 CFR 812.140(a)(3)(i)). Dr. Lazzaro committed to providing a written response within 15 working days, addressing each observation with corrective and preventive actions, and ensuring ongoing review and reporting of all identified deviations to the IRB.