Shionogi Pharma Co. Ltd. – FDA 483, Aug 28, 2026

An FDA inspection of Shionogi Pharma Co., LTD in Tokushima, Japan, an API and intermediate manufacturer, revealed significant deficiencies across its quality, production, and laboratory systems. Observations included inadequate documentation practices with out-of-sequence entries, insufficient equipment cleaning and maintenance procedures, and analytical methods that did not meet USP requirements. The firm failed to provide scientific rationale for potential quality impacts.