# FDA 483 - Kite Pharma, Inc. - November 01, 2024

Source: https://www.keypedia.com/records/483/kite-pharma-inc/242de29c-a425-4452-8142-20c92fa30e91

> FDA 483 for Kite Pharma, Inc. on November 01, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Kite Pharma, Inc.
- Inspection Date: 2024-11-01
- Product Type: drugs
- Office Name: Office of Regulatory Affairs
- Summary: Kite Pharma, Inc. in Frederick, MD, a finished product drug manufacturer, was cited for failing to report serious and unexpected adverse experiences to the FDA within the required 15 calendar days. The inspection, conducted from October 28 to November 1, 2024, revealed 11 instances where reports were delayed by 17 to 159 days, indicating a significant lapse in regulatory reporting compliance.

## Related Documents

- [483 - 2024-11-01](https://www.keypedia.com/records/483/kite-pharma-inc/c5c72e0e-a53d-4e4f-b654-971ddbcf3c85)

## Related Officers

- [Peng Zhou](https://www.keypedia.com/people/peng-zhou/ce413ab5-8787-4012-bc8f-9ef55f2c3dc1)
- [Richard L. Bartlett](https://www.keypedia.com/people/richard-l-bartlett/602337b9-ac77-41bb-a254-71a9d345335b)
- [FDA_PERSONNEL](https://www.keypedia.com/people/lizaida-perez/686fbdca-bfd7-4a73-990a-d8a97e6b88b7)

Company: https://www.keypedia.com/companies/kite-pharma-inc/3b951fdd-ddaa-4306-bff9-aee14a93c6d5

Office: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64