483
UNIVAR SOLUTIONS USA INC.UNIVAR SOLUTIONS USA INC. – FDA 483, Aug 11, 2023
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.
View Company Profile
ID · c4184724-6e48-4dd0-80ed-deed5b7e121f
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.