SK Life Science Inc. – FDA EIR, Aug 11, 2021

An FDA inspection of SK Life Science Inc., conducted from August 2 to August 11, 2021, revealed significant deficiencies in the company's post-marketing adverse drug experience (PADE) reporting processes. The inspection, carried out under regulatory frameworks such as 21 CFR 314.80 concerning drug adverse event reporting, resulted in a Form FDA 483 listing several observations. Key violations included the absence of adequate written procedures for reporting post-marketing ADEs to the FDA, specifically lacking guidelines for electronic submissions, required timeframes for non-alert ADEs, and essential elements for periodic reports. Furthermore, the company failed to submit seven serious and unexpected adverse drug experiences to the FDA within the mandated 15-day alert period and neglected to include twenty-nine non-alert adverse event reports in their periodic safety reports. The inspection also identified a failure to consistently follow internal standard operating procedures for overseeing outsourced pharmacovigilance activities and performing regular reconciliations of safety reports. In response, SK Life Science's CEO and President, Jeong Woo Cho, and his team acknowledged the findings. They committed to immediately submitting the outstanding safety reports, revising their written procedures to align with FDA requirements, and implementing corrective actions to prevent future reporting delays. The company also promised to provide a comprehensive written response to the FDA 483 within 15 business days.