FDA 483 - Samchundang Pharm Co., Ltd. - October 25, 2019

This 483 report for Samchundang Pharm Co., Ltd. details significant deficiencies across multiple quality system areas, including quality control unit responsibilities, personnel training, complaint handling, data integrity, aseptic processing, environmental monitoring, and laboratory controls. The observations highlight a lack of written procedures, inadequate adherence to established SOPs, and insufficient validation and testing practices for US-marketed products. These issues collectively indicate a systemic failure to ensure product quality, purity, strength, and compliance with GMP regulations.