FDA 483 - Marcello M. Rotta, MD - November 23, 2020

The FDA inspected Marcello M. Rotta, MD, a clinical investigator in Denver, CO, from November 17-23, 2020. The inspection revealed significant deficiencies in the conduct of clinical investigations, including failures to report serious adverse events in a timely manner and inadequate oversight of study staff. Additionally, the firm failed to maintain adequate and accurate case histories and legible source documents.