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

During an inspection conducted from September 29 to October 9, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Haisco-USA Pharmaceuticals, Inc. at its Bridgewater, NJ corporate headquarters. The primary observation highlighted the firm's failure to ensure proper monitoring of a clinical study, specifically the protocol titled "(b)(4)". This lapse resulted in inadequate data verification by their contract research organization (CRO), leading to the enrollment of study subjects who did not meet established protocol inclusion and exclusion criteria.

Examples cited by the FDA included multiple subjects across different sites whose screening vital signs, such as heart rate or systolic blood pressure, were outside the defined eligibility thresholds. Despite these discrepancies in source data, the CRO monitor had verified these subjects as meeting all criteria during routine monitoring visits. This indicates a significant oversight in ensuring the study's adherence to its investigational plan. While an FDA Form 483 lists observations and is not a final determination of compliance, Haisco-USA Pharmaceuticals, Inc. is expected to address these findings and implement corrective actions to ensure regulatory adherence, particularly concerning clinical trial oversight and data integrity under the Federal Food, Drug, and Cosmetic Act.