Juno Therapeutics, Inc.September 20, 2023

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

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Record Details

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.

Company: Juno Therapeutics, Inc.
Inspection Date: September 20, 2023
Product Type: Biologics
Office: Division of Pharmaceutical Quality Operations IV
People: Christopher R. Czajka (Consumer Safety Officer (Inspector))
Michael Araneta (issuing_officer)

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ID · f7d043e3-804a-4af3-b3ca-45b4a7ad9a01