FDA 483 - Yakult Honsha Co., Ltd. - November 12, 2026

An FDA inspection of Yakult Honsha Co., Ltd. in Susono, Japan, an API manufacturer, revealed two significant observations. Issues included inadequate qualification of working standards for in-process and finished product testing, relying on outdated historical data. Additionally, the firm's out-of-specification and deviation investigations lacked proper control over handwritten notes, raising concerns about data integrity and completeness of records.