FDA 483 - Samsung Biologics Co., Ltd. - May 27, 2025

Samsung Biologics Co., Ltd. in Yeonsu Incheon, Korea, a drug substance manufacturer, was cited for significant deficiencies across multiple areas during an FDA inspection. Observations included failures to follow cross-contamination prevention procedures, widespread data integrity issues within the quality control unit, and inadequate quality control laboratory procedures for drug substance testing and waste disposal. Additionally, the firm implemented changes to an approved application and released drug substance batches without prior FDA approval.