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

Source: https://www.keypedia.com/records/483/scilex-pharmaceuticals-inc/adf6d84f-8c56-4954-9579-022eec9eedf8

> FDA 483 for Scilex Pharmaceuticals Inc. on May 20, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Scilex Pharmaceuticals Inc.
- Inspection Date: 2026-05-20
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: 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.

## Related Officers

- [Kristin M. Abaonza](https://www.keypedia.com/people/kristin-m-abaonza/cf909da8-837d-4dfe-9ccc-288b24d7bba3)

Company: https://www.keypedia.com/companies/scilex-pharmaceuticals-inc/de4ca2fe-59db-4bc6-bf04-c3a4d7db1987

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b