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

Source: https://www.keypedia.com/records/483/sunsho-pharmaceutical-co-ltd/780ad205-4cf6-49dd-bfb4-6292d2eaca8c

> FDA 483 for Sunsho Pharmaceutical Co., Ltd. on April 17, 2025. Product: drugs. 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: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Sunsho Pharmaceutical Co., Ltd. in Fuji-shi, Shizuoka, Japan, a dietary supplement manufacturer, received a Form 483 with five observations. The inspection revealed significant deficiencies in establishing specifications for components and finished products, using scientifically valid testing methods, and maintaining complete batch and master manufacturing records. These issues indicate a lack of adequate controls to ensure the quality and identity of dietary supplements for the U.S. market.

## 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/98d043a8-2d3e-4b32-b1e8-e6a08e94541d

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