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

Source: https://www.keypedia.com/records/483/sunsho-pharmaceutical-co-ltd/30f83c67-a63c-4f21-b469-b737a5f40b42

> FDA 483 for Sunsho Pharmaceutical Co., Ltd. on April 17, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sunsho Pharmaceutical Co., Ltd.
- Inspection Date: 2025-04-17
- Product Type: other
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

- [investigator](https://www.keypedia.com/people/diana-k-krepel/6dfec9cd-a933-4d1e-947c-cebb5891796c)

Company: https://www.keypedia.com/companies/sunsho-pharmaceutical-co-ltd/429e8059-a116-43da-a0b6-9c58bdb21868

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8