FDA 483 - Celltrion Pharm, Inc. - September 14, 2023

An FDA inspection of Celltrion Pharm, Inc. in Cheongju-si, Korea, a drug manufacturer, revealed significant deficiencies in their quality management system. The firm failed to adequately establish procedures for finished device acceptance, corrective and preventive actions, and management review. These issues indicate a lack of robust controls over product quality and system oversight.