Samsung Biologics Co., Ltd.February 20, 2023

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

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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.

Company: Samsung Biologics Co., Ltd.
Inspection Date: February 20, 2023
Product Type: Biologics
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Prabhu P. Raju (Program Expert for Advanced Manufacturing )

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ID · ddfd6afc-35be-427a-aeee-027047c73e7d