# FDA 483 - Samsung Biologics Co., Ltd. - June 09, 2022

Source: https://www.keypedia.com/records/483/samsung-biologics-co-ltd/caf2bc64-dcd8-4d80-a40d-ca04258e6266

> FDA 483 for Samsung Biologics Co., Ltd. on June 09, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Samsung Biologics Co., Ltd.
- Inspection Date: 2022-06-09
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Samsung Biologics Co., Ltd. in Incheon, Korea, was cited for significant deficiencies in quality control and aseptic processing during an FDA inspection. Observations included an unreliable endotoxin detection method, inadequate cleaning procedures for RABS, and insufficient investigations into high invalid assay rates for critical product testing. These issues indicate a lack of robust quality systems and control over manufacturing processes.

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## Related Officers

- [Madushini N. Dharmasena](https://www.keypedia.com/people/madushini-n-dharmasena/c6dbff15-4c5f-475e-8ec1-581d8e65f76c)

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