FDA 483 - HK INNO.N CORPORATION - January 24, 2025

An FDA inspection of Inno.N Corporation in Heungdeok-gu, Cheongju-si, Chungbuk, Republic of Korea, revealed significant deficiencies across its sterile drug product manufacturing operations. Key issues included inadequate validation of sterilization processes, failures in environmental monitoring, and insufficient laboratory controls for microbial testing. The firm also exhibited problems with visual inspection procedures, incomplete investigations into discrepancies, and a lack of proper quality control unit authority and personnel training, indicating a systemic lack of control over critical manufacturing and quality assurance processes.