Celltrion Inc. – FDA Warning Letter, Jun 2, 2017

The FDA issued a Warning Letter to Celltrion, Inc. following an inspection from May 22 to June 2, 2017, at their Incheon, Republic of Korea drug manufacturing facility. The letter identifies significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to prevent microbiological contamination (21 CFR 211.113(b)):** Observed poor aseptic practices, such as an operator disrupting unidirectional airflow in a Restricted Access Barrier System (RABS) by reaching over sterile stoppers. The firm's response was inadequate, lacking retrospective investigation and a thorough risk assessment. Deficiencies were also noted in smoke studies, which lacked evaluation of dynamic conditions, and media fill validations, including inappropriate rejection of integral vials, inadequate personnel participation requirements, and insufficient training/documentation for media fill unit examination. 2. **Failure to thoroughly investigate discrepancies (21 CFR 211.192):** The firm failed to resolve recurring complaints (approx. 140) from October 2015 to May 2017 regarding lack of (b)(4) in vials, attributed to vial stopper issues. Investigations were prolonged, and a biological product deviation report was not submitted to FDA. Additionally, the