FDA 483 - United Therapeutic Corporation - February 11, 2025

An FDA inspection of United Therapeutic Corporation in Beltsville, MD, revealed significant deficiencies in both its testing laboratory and warehouse operations. The firm failed to implement appropriate computer system controls, leading to data integrity concerns with weighing scales and instrument data. Additionally, the inspection found issues with inventory control, including the improper identification and storage of quarantined, rejected, and expired materials, and a failure to utilize the ERP system for managing warehouse inventories.