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

Astellas Pharma Inc., a drug substance manufacturer in Takahagi, Japan, was cited for two observations during an FDA inspection. The firm's Quality Unit responsibilities were not fully documented, specifically lacking a control strategy for potential impurities in drug substance. Additionally, computerized systems used for particle size distribution lacked sufficient controls to prevent unauthorized data changes, including deletable raw data and absent audit trails for deletions.