# FDA 483 - Seoul Cosmetics Co., Ltd. - February 03, 2023

Source: https://www.keypedia.com/records/483/seoul-cosmetics-co-ltd/d5772d64-e405-4eef-8e0b-417a38ec8059

> FDA 483 for Seoul Cosmetics Co., Ltd. on February 03, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Seoul Cosmetics Co., Ltd.
- Inspection Date: 2023-02-03
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Seoul Cosmetics Co., Ltd. in Namdong, Incheon, Korea, a drug manufacturer, was inspected by the FDA and received a Form 483 with six observations. The inspection revealed significant deficiencies across quality systems, facilities and equipment, laboratory controls, production, and materials systems. Key issues included a lack of process validation, inadequate stability data, unvalidated equipment, deficient test methods with data integrity concerns, and insufficient raw material and in-process testing.

## Related Documents

- [WARNING_LETTER - 2023-02-03](https://www.keypedia.com/records/warning_letter/seoul-cosmetics-co-ltd/2fcec189-e770-4433-92b4-fa967bf3e322)

## Related Officers

- [Approval Manager](https://www.keypedia.com/people/michael-h-tollon/5e30e7e1-5727-4169-8faf-e5d5783ac781)

Company: https://www.keypedia.com/companies/seoul-cosmetics-co-ltd/0fac7bc6-ee8a-4f60-bfb2-4757ff2cefe1

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1