FDA 483 - Univar Solutions, LLC. - April 12, 2024

Univar Solutions, LLC. in Commerce, CA, a repacker of pharmaceutical products, received a Form 483 with four observations. The inspection revealed significant deficiencies in quality control, including the absence of a defined quality control unit, lack of annual product reviews, and inadequate independent verification of master batch records. Additionally, the firm failed to validate laboratory equipment and maintain proper data integrity controls for automated systems.