# FDA 483 - Samsung Biologics Co., Ltd. - February 20, 2023

Source: https://www.keypedia.com/records/483/samsung-biologics-co-ltd/ddfd6afc-35be-427a-aeee-027047c73e7d

> FDA 483 for Samsung Biologics Co., Ltd. on February 20, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Samsung Biologics Co., Ltd.
- Inspection Date: 2023-02-20
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Samsung Biologics Co., Ltd. in Yeonsu-gu, Incheon, Republic of Korea, revealed significant deficiencies in their quality control unit, including data integrity violations and incomplete investigations. The inspection also cited issues with the requalification of reference standards and inadequate control over incoming final containers. These findings indicate a lack of robust quality system oversight.

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## Related Officers

- [Program Expert for Advanced Manufacturing ](https://www.keypedia.com/people/prabhu-p-raju/2c0aaede-fe16-4431-bc21-614d7f18cb32)

Company: https://www.keypedia.com/companies/samsung-biologics-co-ltd/817b7bc4-2de1-47f4-b552-178303c8da01

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd