FDA 483 - Oishi Koseido Co., Ltd. - September 01, 2023

An FDA inspection of Oishi Koseido Co., Ltd. in Tosu, Japan, revealed significant deficiencies in their quality control and manufacturing processes. The firm was cited for multiple data integrity issues, including missing raw data, unmonitored changes to electronic records, and inadequate audit trail reviews. Other concerns included a lack of proper change management for new facility construction, absence of a written stability testing program, and insufficient documentation for equipment maintenance and reserve sample examinations.