FDA 483 - RayzeBio, Inc - February 24, 2026

RayzeBio, Inc. received a Form 483 citing significant deficiencies across its quality control, aseptic processing, and laboratory operations. The observations highlight a systemic lack of written procedures, inadequate validation, poor environmental monitoring, and insufficient investigation into deviations and excursions, impacting the quality and sterility assurance of its drug products.