FDA 483 - Michael Lissy, M.D. - May 09, 2025

During an inspection conducted from May 5-9, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Michael Lissy, M.D., a Clinical Investigator associated with Nuvisan GmbH in Neu-Ulm, Bavaria, Germany. The inspection identified a significant observation concerning the failure to prepare or maintain adequate case histories, which impacted a clinical study. Specifically, critical study documentation was compromised. Sealed paper code break emergency envelopes, intended for emergency unblinding of subject treatment, were destroyed on May 2, 2024, after the study concluded on October 7, 2023. This prevented FDA investigators from verifying the integrity of the seals and confirming the accuracy of subject randomization assignments. Additionally, the study protocol required subjects to rest in a supine position for at least five minutes before vital sign measurements. For all 26 enrolled subjects, neither the paper casebooks nor the electronic case report forms documented adherence to this pre-measurement resting period, affecting all vital sign data collected. These findings indicate deficiencies in record-keeping and protocol adherence, crucial for data integrity and participant safety in clinical research. The FDA's report, issued under Section 704(b) of the Federal Food, Drug and Cosmetic Act, requires the clinical investigator to propose corrective actions to address these observations.