# FDA 483 - Juno Therapeutics, Inc. - October 16, 2020

Source: https://www.keypedia.com/records/483/juno-therapeutics-inc/2752e95f-f049-4f3d-8b35-a736c090e366

> FDA 483 for Juno Therapeutics, Inc. on October 16, 2020. Product: Biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Juno Therapeutics, Inc.
- Inspection Date: 2020-10-16
- Product Type: Biologics
- Office Name: Division of Manufacturing and Product Quality
- Summary: The FDA Form 483 details observations from an inspection, highlighting several deficiencies in quality control and manufacturing processes.

**Key Violations and Observations:**

*   **Inadequate Discrepancy Review (DEV-2019-03442, Critical Classification):** The review of a critical discrepancy involving a (b)(4) result was deficient.
    *   The reliability of the vendor's Certificate of Analysis (CoA) for (b)(4) lots was not established, impacting the quality assessment of previously released lots.
    *   The clinical impact analysis for potential (b)(4) exposure was incomplete, lacking an assessment of adverse events.
    *   A Corrective Action and Preventive Action (CAPA) with effectiveness checks, as per SOP-001151, was not initiated for this critical deviation to address inconsistencies between contract lab and vendor results. Effectiveness checks for implemented corrections were also not conducted.
    *   The investigation did not include an OOS investigation by the (b)(4) vendor, as required by SOP-001145, to validate their assay results.

*   **Improper Classification of Investigations:** Several Notice of Events (NOEs) were not classified as Deviations, despite potential product impact:
    *   DEV-2020-02527: Suspected (b)(4) during (b)(4) of Lot (

## Related Documents

- [EIR - 2020-10-16](https://www.keypedia.com/records/eir/juno-therapeutics-inc/5d0557ed-802a-4be8-beae-10ba56c6fb3a)
- [483_RESPONSE - 2020-10-16](https://www.keypedia.com/records/483_response/juno-therapeutics-inc/0b08be96-ed05-44b4-ba0b-d22ea402bb5e)
- [483 - 2023-09-20](https://www.keypedia.com/records/483/juno-therapeutics-inc/f7d043e3-804a-4af3-b3ca-45b4a7ad9a01)

## Related Officers

- [Program Expert for Advanced Manufacturing ](https://www.keypedia.com/people/prabhu-p-raju/2c0aaede-fe16-4431-bc21-614d7f18cb32)
- [Eileen A. Liu](https://www.keypedia.com/people/eileen-a-liu/fa051db4-1242-4181-9af9-5b3cd2de5689)

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

Office: https://www.keypedia.com/offices/division-of-manufacturing-and-product-quality/fc43149e-8541-426d-b1cd-b07e8a729a2d