FDA 483 - RAYZEBIO INC - February 24, 2026

This document outlines the regulatory basis for FDA Form 483, which reports objectionable conditions observed during an inspection. Issued under Section 704(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act, the form is used to notify a company management of practices that may violate safety standards. Specifically, it addresses concerns where products—including food, drugs, devices, or cosmetics—may consist of decomposed substances or were prepared and stored under unsanitary conditions that could lead to contamination or health risks. While this specific excerpt does not list a specific company name or inspection dates, it establishes the legal framework requiring FDA investigators to provide written reports of their findings to facility owners or operators before concluding an inspection. The primary goal is to assist firms in achieving compliance with federal regulations. Recipients are expected to review these observations and take corrective actions to ensure product safety and quality, as these reports are also shared with the Secretary of Health and Human Services to document potential regulatory non-compliance.