FDA 483 - Univar Solutions USA LLC - October 29, 2024

Univar Solutions USA, a drug repacker and relabeler in Morrisville, PA, was cited for significant deficiencies in laboratory controls, material testing, and quality unit oversight. Observations included failures in raw material identification testing, inadequate storage conditions for drug products, and a lack of qualified personnel to ensure product quality and data integrity. These issues indicate a systemic breakdown in quality assurance processes.