# FDA 483 - Samsung Biologics Co., Ltd. - July 30, 2024

Source: https://www.keypedia.com/records/483/samsung-biologics-co-ltd/6e40e6e0-81d7-4a42-b6e2-13cc55efe248

> FDA 483 for Samsung Biologics Co., Ltd. on July 30, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Samsung Biologics Co., Ltd.
- Inspection Date: 2024-07-30
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Samsung Biologics Co., Ltd. in Incheon, Republic of Korea, received a Form 483 citing significant deficiencies in its drug substance and drug product manufacturing. Observations included inadequate aseptic processing controls, poor investigation practices for deviations and environmental monitoring excursions, and insufficient data integrity controls for electronic systems. The firm also faces concerns regarding cleaning validation, high rates of laboratory system suitability test failures, and incomplete bioreactor validation.

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## Related Officers

- [Yiwei Li, Ph.D., Supervisory Chemist](https://www.keypedia.com/people/yiwei-li-phd-supervisory-chemist/25391f15-b3ee-400e-9e10-4fc2b674facc)
- [Jin Sung Hong, Ph.D., Interdisciplinary Scientist](https://www.keypedia.com/people/jin-sung-hong-phd-interdisciplinary-scientist/59abf7fa-6907-4cbc-83eb-d78445e65cef)
- [Suhong Li, Ph.D., Chemist](https://www.keypedia.com/people/suhong-li-phd-chemist/668c07ca-7653-4e9c-b3c4-65cec9846781)
- [Zhong Li, Ph.D., Sr. Pharmaceutical Quality Assessor](https://www.keypedia.com/people/zhong-li-phd-sr-pharmaceutical-quality-assessor/cdc177bb-92f6-4d53-ba84-6e878c68917a)
- [Charles Kao, Ph.D., Pharmaceutical Scientist](https://www.keypedia.com/people/charles-kao-phd-pharmaceutical-scientist/d6b80c20-f094-4ecb-8abe-da2e81740dff)

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