FDA 483 - Astellas Pharma Inc. - June 06, 2025

Astellas Pharma Inc. in Takaoka, Japan, a sterile drug product manufacturer, received two observations during an FDA inspection. The firm failed to establish adequate written procedures for production and process controls, specifically regarding the visual inspection of injection vials and the qualification of visual inspectors. Additionally, procedures designed to prevent microbiological contamination of sterile drug products were found deficient due to an inadequate disinfectant efficacy study.