Scilex Pharmaceuticals Inc. – FDA 483, May 20, 2026

An FDA inspection of Scilex Pharmaceuticals Inc. in Palo Alto, CA, identified a significant deficiency related to post-marketing adverse drug experience reporting. The firm lacked written procedures for the surveillance, receipt, evaluation, and reporting of adverse events, particularly those identified through social media monitoring for its products ELYXYB, GLOPERBA, and ZTLIDO. This indicates a potential risk in the timely and systematic reporting of drug safety information to the FDA.