FDA 483 - David M. Lubeck MD - April 20, 2022

David M. Lubeck MD, a sponsor-investigator in Orland Park, IL, was cited for significant deficiencies in conducting a clinical investigation. The firm initiated an IND-required study before the IND was in effect, failed to maintain adequate case histories, and did not follow the investigational plan. These issues indicate a lack of adherence to regulatory requirements for clinical trials.