# FDA EIR - Kite Pharma, Inc. - August 20, 2019

Source: https://www.keypedia.com/records/eir/kite-pharma-inc/81acca23-a0c1-41dd-ac8f-cf1ad0c991bd

> FDA EIR for Kite Pharma, Inc. on August 20, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: EIR
- Company Name: Kite Pharma, Inc.
- Inspection Date: 2019-08-20
- Product Type: biologics
- Office Name: Team Biologics
- Summary: An FDA Level 1 GMP inspection of Kite Pharma, Inc., a manufacturer of licensed biological products (CAR-T cells like YESCARTA®), was conducted from August 12-20, 2019. This was the firm's first post-market GMP inspection since its U.S. FDA licensure in October 2017, conducted under the OBPO/Team Biologics FY19 work plan and Compliance Program 7345.848. The comprehensive review covered Quality, Production, Facilities & Equipment, Materials, Laboratory, and Packaging & Labeling systems. At the inspection's conclusion, Kite Pharma was issued a FORM FDA 483, documenting three objectionable conditions. These included a lack of assurance regarding the proper assessment of the potency method's accuracy, the failure to report a 2018 timepoint failure as a biological product deviation, and the absence of initial verification for a supplier's test results according to established procedures. Management committed to providing a written response detailing corrective actions to the U.S. FDA.

## 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)
- [483 - 2021-10-22](https://www.keypedia.com/records/483/kite-pharma-inc/fa4d9c4c-8314-49c9-a71d-7624cebe810a)
- [483 - 2025-08-27](https://www.keypedia.com/records/483/kite-pharma-inc/9d582659-17ed-4a21-853c-0b801964dc32)

## Related Officers

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

Office: https://www.keypedia.com/offices/team-biologics/05484e1e-6fab-47a3-b680-ec2a393a202f