# FDA 483 - SUNJIN BEAUTY SCIENCE CO., LTD - August 01, 2025

Source: https://www.keypedia.com/records/483/sunjin-beauty-science-co-ltd/176e5dc0-dece-4dee-9fe6-846a460e3ea2

> FDA 483 for SUNJIN BEAUTY SCIENCE CO., LTD on August 01, 2025. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SUNJIN BEAUTY SCIENCE CO., LTD
- Inspection Date: 2025-08-01
- Product Type: other
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of SUNIN BEAUTY SCIENCE CO., LTD in Seocheon County, Korea, identified significant deficiencies across multiple quality systems. The firm failed to adequately investigate contamination and out-of-specification events, lacked stability data to support product retest dates, and demonstrated inadequate validation for both a critical production system and cleaning procedures. These issues raise concerns about the quality control of drug products distributed to the US market.

## Related Officers

- [Carolina D. Vasquez](https://www.keypedia.com/people/carolina-d-vasquez/ffa9d542-e660-4575-831e-f11a2de4b978)

Company: https://www.keypedia.com/companies/sunjin-beauty-science-co-ltd/0493baf3-a84e-4f0c-b27f-d1344c0743ed

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