FDA 483 - Marina Elena Cazzaniga, MD - November 21, 2025

Marina Elena Cazzaniga, MD, a clinical investigator in Monza, Italy, was cited for significant deficiencies in conducting clinical studies. The inspection revealed multiple discrepancies between source documents and electronic Case Report Forms (eCRF) for investigational drug subjects, indicating poor data integrity. Additionally, the firm failed to obtain proper informed consent for the collection of biological samples from two subjects.