FDA 483 - Natuzen Co.,Ltd. - November 21, 2024

An FDA inspection of Natuzen Co., Ltd., a contract manufacturer in Namdong, Incheon, revealed significant deficiencies in their quality system for future OTC drug production. Observations included failures to establish written procedures for production and process controls, inadequate laboratory controls, lack of GMP training for employees, and unwritten responsibilities for the quality control unit. These issues indicate a lack of foundational controls necessary to assure drug product quality and compliance.