Sunsho Pharmaceutical Co., Ltd.April 17, 2025

FDA 483 - Sunsho Pharmaceutical Co., Ltd. - April 17, 2025

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Record Details

Sunsho Pharmaceutical Co., Ltd. in Fuji-shi, Shizuoka, Japan, was inspected regarding its dietary supplement manufacturing operations. The inspection revealed significant deficiencies in establishing and following specifications for components and finished products, as well as issues with record-keeping and process control. These observations indicate a lack of robust quality control and adherence to manufacturing regulations.

Company: Sunsho Pharmaceutical Co., Ltd.
Inspection Date: April 17, 2025
Product Type: Other
Office: Office of Inspections and Investigations
Person: Diana K. Krepel (investigator)

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ID · 30f83c67-a63c-4f21-b469-b737a5f40b42