Shionogi Pharma Co. Ltd. – FDA 483, Oct 20, 2023

Shionogi Pharma Co., Ltd. in Tokushima, Japan, was cited for significant deficiencies across its quality control and manufacturing processes. Observations included inadequate Out-of-Specification investigations, unvalidated analytical and cleaning methods, and insufficient laboratory controls. Additionally, the firm's water sampling practices were found to be unrepresentative, and microbial risk assessments were lacking.