Samsung Biologics Co., Ltd.June 26, 2018

FDA 483 - Samsung Biologics Co., Ltd. - June 26, 2018

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Record Details

An FDA inspection of Samsung Biologics Co. Ltd. in Yeonsu, Incheon, a sterile drug manufacturer, revealed significant deficiencies across three observations. The firm was cited for inadequate training of visual inspectors, issues with equipment design and calibration records, and insufficient detail in cleaning and maintenance procedures for critical surfaces. These findings indicate a need for improved quality control and adherence to good manufacturing practices.

Company: Samsung Biologics Co., Ltd.
Inspection Date: June 26, 2018
Product Type: Drugs
Office: Office of Biological Products Operations - Division I
People: Lucila B. Nwatu (National Program Expert- Pharmacy Compounding)
Deborah H. Schmiel

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ID · f30ce007-aebc-4adb-b5d0-3fe2fcb25da0