FDA 483 - Ferring Microbiome Inc. - July 09, 2018

An FDA inspection of Rebiotix, a clinical study sponsor, revealed significant deficiencies in the monitoring of investigational studies. The firm failed to ensure proper adherence to study protocols, including issues with unauthorized personnel handling investigational products, incomplete product accountability logs, and untimely submission of monitoring reports and follow-up letters. These findings indicate a lack of adequate oversight in the conduct of their clinical trials.