FDA 483 - Samsung Biologics Co., Ltd. - July 30, 2024

During an inspection conducted from July 22 to July 30, 2024, the FDA identified significant Good Manufacturing Practice (GMP) deficiencies at Samsung Biologics Co., Ltd.'s drug substance and drug product manufacturing facility in Incheon, Republic of Korea. The inspection revealed critical issues primarily related to aseptic processing, quality system investigations, data integrity, and process validation.

Key violations included inadequate procedures to prevent microbiological contamination of sterile products, evidenced by flawed airflow visualization studies, poor aseptic techniques by operators, and deficiencies in aseptic system design and environmental monitoring. The company also demonstrated systemic failures in investigating unexplained discrepancies and implementing effective corrective actions, with numerous recurring deviations attributed to "human error" without thorough root cause analysis.

Furthermore, the inspection highlighted substantial data integrity concerns, such as inadequate access controls for computerized systems (e.g., shared administrator accounts, excessive user privileges), incomplete analytical data processing, a lack of raw data backup for environmental monitoring, and uncontrolled deletion of QC projects. The visual inspection program for sterile products was also found to be deficient, lacking adherence to internal procedures and independence in qualification. Additionally, inadequate contamination control risk assessments, ineffective cleaning validation, and insufficient validation of all production bioreactors were cited.

Samsung Biologics is required to implement comprehensive corrective and preventive actions to address these serious deficiencies across its quality systems, manufacturing processes, and laboratory controls to ensure compliance with regulatory expectations and safeguard drug product quality.