# FDA 483 - Juno Therapeutics, Inc. - September 20, 2023

Source: https://www.keypedia.com/records/483/juno-therapeutics-inc/f7d043e3-804a-4af3-b3ca-45b4a7ad9a01

> FDA 483 for Juno Therapeutics, Inc. on September 20, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Juno Therapeutics, Inc.
- Inspection Date: 2023-09-20
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Juno Therapeutics, Inc. in Bothell, WA, received a Form 483 following an inspection from September 11-20, 2023, for its cell therapy manufacturing. The inspection revealed significant deficiencies in aseptic processing, quality control unit procedures for complaint handling, and adherence to written procedures for equipment maintenance. These observations indicate a need for improved adherence to established manufacturing and quality systems.

## Related Documents

- [EIR - 2020-10-16](https://www.keypedia.com/records/eir/juno-therapeutics-inc/5d0557ed-802a-4be8-beae-10ba56c6fb3a)
- [483 - 2020-10-16](https://www.keypedia.com/records/483/juno-therapeutics-inc/2752e95f-f049-4f3d-8b35-a736c090e366)
- [483_RESPONSE - 2020-10-16](https://www.keypedia.com/records/483_response/juno-therapeutics-inc/0b08be96-ed05-44b4-ba0b-d22ea402bb5e)

## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.keypedia.com/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)
- [issuing_officer](https://www.keypedia.com/people/michael-araneta/c94c95f4-2cda-43f5-a02a-2b5d82fe2c7d)

Company: https://www.keypedia.com/companies/juno-therapeutics-inc/d564709e-29d0-4aaf-9d68-efbf3cd67a35

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