# FDA 483 - Kite Pharma, Inc. - October 22, 2021

Source: https://www.keypedia.com/records/483/kite-pharma-inc/fa4d9c4c-8314-49c9-a71d-7624cebe810a

> FDA 483 for Kite Pharma, Inc. on October 22, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kite Pharma, Inc.
- Inspection Date: 2021-10-22
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Kite Pharma Inc. in El Segundo, CA, received a Form 483 with two observations. The inspection revealed deficiencies in environmental monitoring within aseptic processing areas, specifically regarding the placement and requirement for active viable air sampling in Biological Safety Cabinets. Additionally, the firm failed to promptly perform investigations into serious and unexpected adverse events related to product infections reported via MedWatch.

## 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)

## Related Officers

- [Laurel A. Beer](https://www.keypedia.com/people/laurel-a-beer/0ac1e74f-0ff6-4db6-a0e8-0c3fb013720e)
- [Gene D. Arcy](https://www.keypedia.com/people/gene-d-arcy/a2def947-65fb-4056-84e2-1f89cf944cf0)

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

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