FDA 483 - Univar Solutions USA Inc. - December 11, 2023

An FDA inspection of Univar Solutions USA Inc., a drug repackager and relabeler in Spartanburg, SC, revealed significant deficiencies in its quality system. The firm was cited for a lack of quality unit authority and responsibility in reviewing batch records, incomplete batch production and control records, and failure to follow established laboratory test procedures. These observations indicate a systemic breakdown in cGMP compliance.