FDA 483 - Avotres Inc. - April 24, 2026

An FDA inspection of Avotres Inc.'s Corporate Headquarters in Cedar Knolls, NJ, revealed a significant failure in ensuring proper monitoring of a Phase 1/2 clinical study for AVOTRES Cell-Based Therapy. The firm did not adequately oversee activities delegated to its investigational product manufacturer and failed to ensure that Chain of Custody forms for the investigational product contained all required elements, such as expiration dates. These deficiencies indicate a lack of robust oversight in clinical trial management.