FDA 483 - Univar Solutions USA Inc. - February 21, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 702f97f4-05d7-4342-bd8d-a5616bfbf791