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

An FDA inspection of Univar Solutions USA in Dallas, Texas, revealed significant deficiencies in their quality unit's oversight of API repackaging, including failures in batch record review, procedure establishment, and employee training. The inspection also identified issues with the firm's control and segregation of rejected and expired materials, indicating a lack of robust quality systems. These findings suggest a moderate to severe level of non-compliance with cGMP regulations.