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

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.