FDA 483 - Astellas Pharma Inc. - July 17, 2026

Astellas Pharma Inc. in Yaizu-shi, Shizuoka, Japan, a drug product manufacturer, received a Form 483 with six observations highlighting significant deficiencies. The inspection revealed a lack of adequate controls in aseptic processing, environmental monitoring, visual inspection, equipment maintenance, facility control, and quality oversight. These issues collectively indicate a systemic breakdown in maintaining a controlled manufacturing environment and ensuring product quality and patient safety for sterile drug products.