# FDA 483 - Kite Pharma, Inc. - Unknown Date

Source: https://www.keypedia.com/records/483/kite-pharma-inc/c9fc9405-6666-4b0e-a9f4-673db6960929

> FDA 483 for Kite Pharma, Inc. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kite Pharma, Inc.
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Kite Pharma, Inc. in El Segundo, CA, from June 12-16, 2017, revealed significant deficiencies in the firm's quality systems. Observations included inadequate written procedures for manufacturing and change control, a lack of validated aseptic processing procedures, and insufficient supplier qualification for critical components. The inspection highlighted several areas requiring improved control over manufacturing processes and quality unit responsibilities.

## Related Documents

- [EIR - 2017-06-16](https://www.keypedia.com/records/eir/kite-pharma-inc/df9b181f-24ed-4d65-b182-0d5b152b9529)
- [483 - 2019-08-20](https://www.keypedia.com/records/483/kite-pharma-inc/72dcf3ed-0f1a-4b13-b8ac-1c8599f6c7a2)
- [483 - 2021-10-22](https://www.keypedia.com/records/483/kite-pharma-inc/fa4d9c4c-8314-49c9-a71d-7624cebe810a)

## Related Officers

- [Aric C. Menkhorst](https://www.keypedia.com/people/aric-c-menkhorst/1b21072e-1b57-4489-86cc-ed9b0caf4216)
- [RONALD ERTEL](https://www.keypedia.com/people/ronald-ertel/3372882e-f51a-4dc4-bd51-141bdc89f33f)
- [Simone F. G. Tharkur](https://www.keypedia.com/people/simone-f-g-tharkur/fcb343c2-88ee-4d76-8f5f-651ad192eba6)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd