FDA 483 - Univar Solutions USA Inc. - February 21, 2025

An FDA inspection of Univar Solutions USA in Dallas, Texas, an API manufacturer/repacker, revealed significant deficiencies in its quality unit's oversight of cGMP compliance. The firm failed to adequately review and approve batch records, establish necessary procedures, perform annual product reviews, and ensure proper employee training. Additionally, the inspection found that the firm lacked an effective system for identifying and controlling rejected or expired materials under quarantine.