# FDA 483 - Kite Pharma, Inc. - August 27, 2025

Source: https://www.keypedia.com/records/483/kite-pharma-inc/9d582659-17ed-4a21-853c-0b801964dc32

> FDA 483 for Kite Pharma, Inc. on August 27, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kite Pharma, Inc.
- Inspection Date: 2025-08-27
- Product Type: biologics
- Office Name: Los Angeles District Office
- Summary: Kite Pharma, Inc. in El Segundo, CA, received a Form 483 citing four observations during an FDA inspection. The findings highlight significant deficiencies in record-keeping, computer system validation, process control procedures, and sanitation documentation. These issues indicate a need for improved adherence to Good Manufacturing Practices across critical manufacturing and quality control operations.

## Related Documents

- [EIR - 2017-06-16](https://www.keypedia.com/records/eir/kite-pharma-inc/df9b181f-24ed-4d65-b182-0d5b152b9529)
- [483 - Unknown Date](https://www.keypedia.com/records/483/kite-pharma-inc/c9fc9405-6666-4b0e-a9f4-673db6960929)
- [483 - 2019-08-20](https://www.keypedia.com/records/483/kite-pharma-inc/72dcf3ed-0f1a-4b13-b8ac-1c8599f6c7a2)
- [EIR - 2019-08-20](https://www.keypedia.com/records/eir/kite-pharma-inc/81acca23-a0c1-41dd-ac8f-cf1ad0c991bd)
- [483 - 2021-10-22](https://www.keypedia.com/records/483/kite-pharma-inc/fa4d9c4c-8314-49c9-a71d-7624cebe810a)

## Related Officers

- [Peng Zhou](https://www.keypedia.com/people/peng-zhou/ce413ab5-8787-4012-bc8f-9ef55f2c3dc1)
- [Investigator](https://www.keypedia.com/people/shafiq-s-ahadi/dd146b0a-ca1c-4052-8f50-4d68e14ad73f)
- [Shafiq Ahadi](https://www.keypedia.com/people/shafiq-ahadi/593bbf28-02e6-47bb-86c3-65cbd4ec520d)

Company: https://www.keypedia.com/companies/kite-pharma-inc/5bf88060-db53-466b-9a1c-85be7984894f

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b