FDA 483 - Samsung Bioepis Co., Ltd. - September 15, 2023

Samsung Bioepis Co., Ltd. in Incheon, Korea, was cited for significant deficiencies in its clinical study monitoring and post-marketing adverse event reporting. Observations included a failure to promptly report a subject's death to the FDA and extensive delays in resolving clinical study queries. Additionally, the firm failed to submit numerous 15-day alert reports for serious and unexpected adverse events within the required timeframe.