FDA 483 - Samsung Biologics Co., Ltd. - August 24, 2021

During an FDA inspection, observations were made concerning a manufacturing facility, with issues identified between May and August 2021. The inspection revealed significant concerns regarding inadequate cleaning validation practices and insufficient investigation into manufacturing discrepancies, pointing to deficiencies in the company's quality control systems.

Specifically, the facility's acceptance criteria for cleaning validation were not consistently justified to prevent product cross-contamination. For example, Total Organic Carbon (TOC) limit calculations failed to comprehensively assess cross-contamination risks between different products, and essential degradation studies were not conducted. Additionally, the drying time utilized in swab and rinse TOC recovery verification studies was unrepresentative of the actual dirty hold time for shared process equipment, thus compromising the accuracy of cleaning assessments.

Furthermore, the facility did not consistently investigate discrepancies to identify their root causes and implement adequate corrective actions. An instance of mold detection in a bioreactor hall, attributed to HVAC filter maintenance, lacked a confirmed assessment of filter contamination. Another observation involved bioburden testing where an abnormal sample rinse led to a test repeat, but without a required deviation initiation to investigate the root cause or track recurrence. These observations indicate a need for the company to strengthen its Good Manufacturing Practices by enhancing cleaning validation protocols, thoroughly investigating all deviations, confirming root causes, and implementing comprehensive corrective and preventive actions to ensure product quality and patient safety.