483
Yakult Honsha Co., Ltd.Yakult Honsha Co., Ltd. – FDA 483, Nov 12, 2018
Record Details
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 Issues included inadequate qualification of working standards for in-process and finished product testing, relying on outdated historical data.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.
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ID · 63e9ede0-1fb7-4b2a-ab2f-0adb0a0c9413
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