483
Celltrion Pharm IncCelltrion Pharm Inc – FDA 483, Aug 10, 2026
Record Details
An FDA inspection of Celltrion Pharm Inc. in Cheongju-si, Republic of Korea, a sterile drug manufacturer, revealed significant deficiencies in aseptic processing, cleaning procedures, and quality control. Observations included falsified cleaning records, inadequate validation of visual inspection equipment and personnel, and insufficient environmental monitoring, indicating a serious lack of control over sterile manufacturing operations.
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