FDA 483 - Joseph J.T. Sacco, MD - May 16, 2025

An FDA inspection of Joseph J.T. Sacco, MD, a clinical investigator in Birkenhead, United Kingdom, identified a significant issue with data integrity. The firm failed to prepare or maintain adequate and accurate case histories, specifically by not reporting critical data into the electronic data capture (EDC) system. This omission resulted in incorrect information within the study's electronic case report forms (eCRF).