# FDA 483 - Samsung Biologics Co., Ltd. - September 10, 2019

Source: https://www.keypedia.com/records/483/samsung-biologics-co-ltd/77f6bf66-c495-4acb-9642-77c572ec02e0

> FDA 483 for Samsung Biologics Co., Ltd. on September 10, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Samsung Biologics Co., Ltd.
- Inspection Date: 2019-09-10
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Samsung Biologics Co., Ltd in Incheon, Republic of Korea, a drug substance manufacturer, identified several deficiencies. Observations included inadequate maintenance of utilities and equipment, insufficient written procedures for the transfer of QC materials, and a lack of proper review for employee training. These findings highlight areas requiring improvement in the firm's quality management system.

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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