# FDA 483 - Samsung Biologics Co., Ltd. - August 24, 2021

Source: https://www.keypedia.com/records/483/samsung-biologics-co-ltd/1438e64e-df97-414c-bdce-bd6137243e90

> FDA 483 for Samsung Biologics Co., Ltd. on August 24, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Samsung Biologics Co., Ltd.
- Inspection Date: 2021-08-24
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Samsung Biologics Co., Ltd., a drug substance manufacturer in Incheon, Republic of Korea, was cited with two observations during an FDA inspection. The inspection revealed deficiencies in cleaning validation processes, specifically regarding cross-contamination assessments and dirty hold time studies. Additionally, the firm failed to adequately investigate discrepancies to identify root causes and implement effective corrective actions, as evidenced by issues with mold detection and bioburden testing procedures.

## Related Documents

- [483 - 2025-05-27](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/b3a6afca-acc1-42d3-9eaa-a9c039d1bb0a)
- [483 - 2022-06-09](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/134cfe7e-fea2-4b96-9e87-ef42c2597d55)
- [483 - 2021-08-24](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/f660cf8a-50b8-4766-b37d-4605324fd16b)
- [483 - 2022-06-09](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/caf2bc64-dcd8-4d80-a40d-ca04258e6266)
- [483 - 2018-03-14](https://www.keypedia.com/records/483/samsung-biologics-co-ltd/ce260ba9-5da0-4986-9b6e-3fee4fc334d5)

## Related Officers

- [Yun Wu](https://www.keypedia.com/people/yun-wu/ae378596-ea82-4254-b169-b592878202eb)
- [Chen Sun](https://www.keypedia.com/people/chen-sun/f6a51adc-af97-4e40-aa07-eff034049750)

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