Celltrion Inc. – FDA 483, Jun 3, 2022

CELLTRION, Inc. in Incheon, Republic of Korea, received a Form 483 with seven observations during an FDA inspection from May 23 to June 3, 2022, for deficiencies in drug substance and drug product manufacturing. The inspection revealed significant issues including inadequate procedures to prevent microbiological contamination, failure to establish proper process controls, and poorly designed and maintained equipment. Additionally, the firm was cited for insufficient investigation of deviations and inadequately validated manufacturing systems, indicating a lack of robust quality systems and controls.