FDA 483 - Merit CRO Inc - April 28, 2023

MERIT CRO Inc, a manufacturer in Madison, WI, was inspected from April 25-28, 2023, and received one observation. The inspection revealed that the firm's procedures for controlling nonconforming product are inadequate, specifically regarding the reporting of quality problems that could adversely impact patient health to all affected customers. This includes a failure to notify multiple project sponsors about a software issue that led to incorrect patient eligibility assignments in clinical trials, despite identifying risks of patient injury and data integrity loss.