# FDA 483 - Immunity Bio, Inc - February 10, 2023

Source: https://www.keypedia.com/records/483/immunity-bio-inc/a00ed161-4217-432f-be55-111365031b36

> FDA 483 for Immunity Bio, Inc on February 10, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Immunity Bio, Inc
- Inspection Date: 2023-02-10
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Immunity Bio, Inc. in Culver City, CA, received a Form 483 observation regarding deficiencies in clinical trial oversight. The firm failed to ensure proper monitoring of study QUILT-3.032, specifically concerning missing monitoring visit reports and undocumented site monitoring visits for several sites. This indicates issues with the management and documentation of clinical trial activities.

## Related Officers

- [Jonathan R. Campos](https://www.keypedia.com/people/jonathan-r-campos/f4c6aba7-d0fe-43d2-95ae-5eb86a6659a4)

Company: https://www.keypedia.com/companies/immunity-bio-inc/8f1d4c4c-6ab2-4af1-82dc-3b548b3e14d0

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6