FDA 483 - UBE Corporation - January 26, 2015
Discuss this record with AI
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.
An FDA inspection of Ube API & Intermediates Factory, Ube Chemical Factory, an API manufacturer, revealed significant deficiencies in their quality control systems. Observations included an inadequate Out-of-Specification (OOS) procedure lacking scientific justification for retesting, incomplete and unverified laboratory records, and insufficient monitoring of water system micro attributes. These issues indicate a lack of robust controls over product quality and data integrity.
ID · 10e695f6-7927-4b7b-9f26-ec7b665d3215