UNIVAR SOLUTIONS USA INC.August 11, 2023

FDA 483 - UNIVAR SOLUTIONS USA INC. - August 11, 2023

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Record Details

UNIVAR SOLUTIONS USA INC. in Cincinnati, an API repackager, received a Form 483 with three observations, including a repeat observation from 2021. The inspection revealed significant deficiencies in quality control oversight, component identification testing, and equipment maintenance practices, particularly concerning the repackaging of Isopropanol 99% USP. These issues indicate a lack of adherence to Current Good Manufacturing Practice.

Company: UNIVAR SOLUTIONS USA INC.
Inspection Date: August 11, 2023
Product Type: Drugs
Office: Cincinnati District Office
People: Paranthaman Senthamarai Kannan
Logan T. Williams (Investigator )

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ID · c4184724-6e48-4dd0-80ed-deed5b7e121f