483
Shionogi Pharma Co., Ltd.FDA 483 - Shionogi Pharma Co., Ltd. - March 15, 2019
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Record Details
An FDA inspection of Shionogi & Co., Ltd. in Isawa-gun, Iwate, Japan, an API and sterile drug product manufacturer, revealed significant deficiencies. Observations included inadequate facility cleaning procedures lacking full details and production batch records that failed to consistently identify equipment and location information.
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ID · c4c8272e-ec4e-4289-b741-2c8a3e43d3d1