UBE Corporation – FDA 483, Jan 26, 2015

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.