Univar Solutions USA Inc.December 11, 2023

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

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Record Details

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.

Company: Univar Solutions USA Inc.
Inspection Date: December 11, 2023
Product Type: Drugs
Office: Atlanta District Office
Person: Brittny C. Cargo (Medical Officer at FDA)

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ID · e7d3afe2-bbb5-47bf-9343-d110f2032ac6