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

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 (