FDA 483 - Shionogi Pharma Co., Ltd. - May 30, 2025

Shionogi Pharma Co. Ltd. in Seitsu, Osaka, Japan, was cited for three observations during an FDA inspection. The firm failed to thoroughly review unexplained discrepancies, particularly regarding foreign matter in drug product batches. Additionally, the written stability program was inadequate, not ensuring drug products are tested in their marketed container-closure systems, and procedures for testing incoming components lacked sufficient detail to prevent foreign matter contamination.