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

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.