FDA 483 - Celltrion Inc. - February 27, 2024

This 483 report for Celltrion Inc. details significant deficiencies in aseptic processing, quality unit oversight, and laboratory controls. Issues include inadequate media fill validation, poor environmental monitoring, destruction of original control documents, and insufficient investigations into out-of-specification results. The findings indicate a lack of assurance in the sterility, quality, and purity of drug products manufactured for the US market.