FDA 483 - TERUMO YAMAGUCHI CORPORATION - February 21, 2020

An FDA inspection of Terumo Yamaguchi D&D Corporation in Yamaguchi, Japan, a drug product manufacturer, revealed significant deficiencies across multiple areas. These include inadequate aseptic processing controls, unqualified personnel for critical inspections, insufficient validation of sterile hold times, and a deficient environmental monitoring program. The findings indicate a need for comprehensive improvements in quality systems, equipment maintenance, and personnel training to ensure the sterility and quality of drug products.