483
Joseph J.T. Sacco, MDJoseph J.T. Sacco, MD – FDA 483, May 16, 2025
Record Details
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).
View Company Profile
ID · bc29ec7b-e97b-464a-81ec-97bc48e2807e
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.