FDA 483 - Inotiv, Inc. - July 14, 2022

An FDA inspection of Inotiv, Inc. in Mount Vernon, IN, a nonclinical laboratory, revealed a significant observation regarding the study director's failure to ensure the quality and integrity of nonclinical laboratory studies. Specifically, the study director did not adequately investigate unforeseen circumstances affecting data quality, such as low dose recovery, nor did deviation reports consistently determine root causes or document corrective actions. This indicates issues with data integrity and quality control in their nonclinical studies.