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

An FDA inspection of Michael Lissy, M.D., a clinical investigator in Neu-Ulm, Bavaria, revealed a failure to prepare or maintain adequate case histories for a study protocol. Specifically, issues included the destruction of sealed code break emergency envelopes before verification and a lack of documentation regarding subject positioning for vital sign measurements as required by the protocol. These deficiencies indicate significant concerns with data integrity and adherence to study protocols.