Shionogi Pharma Co., Ltd.March 15, 2019

FDA 483 - Shionogi Pharma Co., Ltd. - March 15, 2019

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.

Company: Shionogi Pharma Co., Ltd.
Inspection Date: March 15, 2019
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Jiao Yang, Ph.D., Chemist
Stephanie A. Slater, M.S., Drug Specialist

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