# FDA 483 - RayzeBio, Inc - February 24, 2026

Source: https://www.keypedia.com/records/483/rayzebio-inc/a3967ced-7a31-459f-9fd1-3e35d6b84509

> FDA 483 for RayzeBio, Inc on February 24, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RayzeBio, Inc
- Inspection Date: 2026-02-24
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: 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.

## Related Officers

- [Investigator](https://www.keypedia.com/people/muna-algharibeh/0f0dbd13-b36a-408d-8e42-4625f8de905d)
- [Scott D. Mcgrew](https://www.keypedia.com/people/scott-d-mcgrew/a9f36e0f-0ae6-42d1-98d2-14e324e2a7fc)

Company: https://www.keypedia.com/companies/rayzebio-inc/2536aed9-c040-4a07-a6fa-853855e83efe

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0