FDA 483 - Everest Life Sciences LLC - April 23, 2025

An FDA inspection of Everest Life Sciences LLC in Plainsboro, NJ, a finished dose and API manufacturer, revealed significant deficiencies across multiple areas. The firm failed to establish adequate controls for process validation, equipment qualification, cleaning validation, laboratory testing, and computer systems. These issues indicate a lack of adherence to cGMP standards, potentially impacting drug product quality and purity.