FDA 483 - Shionogi Pharma Co., Ltd. - September 20, 2025

An FDA inspection conducted on June 20, 2023, at Shionogi Pharma Co. Ltd., a drug manufacturer in Settsu, Osaka, Japan, identified several significant quality system deficiencies. The observations, documented in an FDA Form 483, highlighted critical issues across their laboratory and materials systems, indicating non-compliance with current Good Manufacturing Practices (cGMP).

A primary concern in the laboratory system was the company's failure to thoroughly investigate unexplained discrepancies. Specifically, foreign matter particles detected during the production of drug granules were not adequately investigated to determine their source or composition, even for batches already distributed. This raises concerns about product purity and the robustness of contamination control.

Additionally, the firm's written stability program was found to be inadequate, as it did not ensure that drug product stability samples for tablets and granules were stored and tested in the same container-closure systems used for market distribution. This practice compromises the validity and relevance of stability data.

In the materials system, the FDA observed a lack of sufficiently detailed written procedures for component testing. The method used for inspecting incoming excipient lots for tablets failed to effectively detect or prevent foreign matter particles below a certain size. This deficiency could lead to the introduction of contaminants into finished drug products, impacting their identity and purity.

Shionogi Pharma Co. Ltd. is required to respond to these findings by developing and implementing comprehensive corrective actions to address the identified issues and ensure ongoing regulatory compliance and product quality.