FDA 483 - Celltrion Pharm, Inc. - July 22, 2024

An FDA inspection of Celltrion Pharm, Inc., a sterile drug manufacturer in Ochang-eup, South Korea, revealed significant deficiencies across three observations. The firm failed to establish and follow procedures to prevent microbiological contamination, lacked adequate employee training for drug product manufacturing, and had unwritten quality control unit responsibilities and procedures. These issues indicate a moderate to severe level of non-compliance with cGMP regulations.