FDA 483 - Pathogenes, Inc. - November 25, 2022

An FDA inspection of Pathogenes, Inc. in Reddick, FL, a sponsor of clinical trials, revealed significant deficiencies in study oversight. The firm failed to adequately monitor studies, ensure proper reporting of adverse events, and prevent subjects not meeting inclusion criteria from being exposed to investigational products. These observations indicate a lack of adherence to study protocols and good clinical practices.