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

Source: https://www.keypedia.com/records/483/kite-pharma-inc/c5c72e0e-a53d-4e4f-b654-971ddbcf3c85

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

---

## Details

- Record Type: 483
- Company Name: Kite Pharma, Inc.
- Inspection Date: 2024-11-01
- Product Type: drugs
- Office Name: Baltimore District Office
- Summary: Kite Pharma, Inc. in Frederick, MD, a finished product drug manufacturer, was inspected by the FDA. The inspection revealed a significant issue with the timely reporting of adverse experiences. Specifically, 11 serious and unexpected adverse experiences were not reported to the FDA within the required 15 calendar days, with delays ranging from 17 to 159 days.

## Related Officers

- [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)
- [Peng Zhou](https://www.keypedia.com/people/peng-zhou/ce413ab5-8787-4012-bc8f-9ef55f2c3dc1)

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

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa