FDA 483 - SK Life Science Inc. - August 11, 2021

SK Life Science Inc. in Paramus, NJ, received a Form 483 with three observations related to inadequate post-marketing adverse drug experience reporting for their product Xcopri. The firm failed to develop adequate written procedures for reporting ADEs, did not submit serious and unexpected ADEs within the required 15-day timeframe, and failed to include non-alert ADEs in periodic safety reports. These issues indicate significant deficiencies in their pharmacovigilance system.