FDA 483 - Vera Therapeutics, Inc. - March 02, 2026

From February 23 to March 2, 2026, the FDA conducted an inspection of Vera Therapeutics, Inc., a clinical study sponsor located in Brisbane, California. The inspection revealed two primary violations regarding the firm’s oversight of clinical investigations under the regulatory framework of the Federal Food, Drug, and Cosmetic Act and 21 CFR 312.

First, the FDA observed that the firm failed to obtain updated Investigator Statements (Form FDA-1572) for three clinical sites. These sites were permitted to enroll subjects in a new phase of a study protocol—which had different objectives than the initial phase—without completing the necessary updated documentation. This failure meant the sponsor did not fulfill its obligation to verify investigator qualifications for the specific study requirements.

Second, the firm failed to ensure proper reporting of serious adverse events (SAEs). Specifically, the electronic data capture system was not configured to collect the dates when clinical sites first became aware of an event. Without this data, the sponsor could not confirm if SAEs were reported within the required timeframes. Furthermore, study monitors did not consistently verify these reporting timelines in their oversight reports.

While these observations are not a final determination of non-compliance, Vera Therapeutics is expected to respond to the FDA. The firm must outline corrective actions to address these documentation and safety monitoring deficiencies to ensure the integrity of its clinical trials.