FDA 483 - Haisco-USA Pharmaceuticals, Inc. - October 09, 2025

An FDA inspection of Haisco-USA Pharmaceuticals, Inc. in Bridgewater, NJ, revealed a significant failure in clinical study monitoring. The firm did not ensure adequate oversight by its contract research organization (CRO), leading to the enrollment of subjects who did not meet protocol-specified inclusion/exclusion criteria. This indicates a serious lapse in data verification and adherence to the investigational plan.