FDA 483 - Maria W. Greenwald, MD - October 27, 2022

An FDA inspection of Maria W. Greenwald, MD, a clinical investigator in Palm Desert, CA, revealed significant deficiencies in the conduct of human clinical studies under INDs. The firm failed to adhere to investigational plans and study protocols, including enrolling ineligible subjects and not reporting protocol deviations to sponsors or IRBs. Additionally, the inspection found a failure to maintain adequate and accurate case histories, resulting in numerous discrepancies in subject medical histories, medications, and adverse event documentation across multiple studies.