FDA 483 - IIT Research Institute - December 01, 2023

An FDA inspection of IIT Research Institute's non-clinical laboratory in Chicago, IL, revealed significant deficiencies in their quality assurance unit, study director oversight, and documentation practices. The firm failed to properly manage and document protocol deviations, accurately record experimental data, and maintain adequate standard operating procedures for nonclinical laboratory studies. These findings indicate a lack of control over critical aspects of their research operations.