FDA 483 - Shionogi Pharma Co., Ltd. - July 01, 2025

Shionogi Pharma Co., Ltd. in Isawa-Gun, Japan, a sterile drug manufacturer, received a Form 483 citing significant deficiencies in its aseptic processing and contamination control. Observations included inadequate procedures for preventing microbiological contamination during interventions, deficiencies in cleaning and disinfection systems, and insufficient validation of aseptic processes through airflow visualization studies. Additionally, the firm lacked adequate controls to prevent cross-contamination of highly potent pharmaceutical products, with multiple instances of contamination detected.