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

The FDA conducted an inspection of Shionogi Pharma Co. Ltd., a drug manufacturing facility located in Settsu, Osaka, Japan, from May 26 to May 30, 2025. During this inspection, several significant issues were identified. Firstly, the company failed to thoroughly investigate unexplained discrepancies related to foreign matter in batches of granules intended for the U.S. market. This oversight could potentially compromise product quality and safety. Secondly, the firm’s stability program was found inadequate as it did not ensure that drug products were tested in the same container-closure system used for their market distribution, which is crucial for maintaining product integrity over time. Lastly, the procedures for testing incoming materials lacked sufficient detail to effectively detect and prevent foreign matter contamination, posing a risk to the purity and identity of the finished drug products.

These observations are reported under Section 704(b) of the Federal Food, Drug, and Cosmetic Act, which mandates that any objectionable conditions or practices observed during an inspection must be documented and communicated to the firm. Shionogi Pharma Co. Ltd. is required to address these issues by implementing corrective actions to ensure compliance with FDA regulations, thereby safeguarding the quality and safety of their pharmaceutical products.