Inspection Record

Juno Therapeutics, Inc. — FDA 483 Findings

US FDAInspected 2020-10-16Published 2020-12-04 3 findingsDeviation, CAPA, and investigationLaboratory and QC controlsOther quality system

View the regulator's official source The source document is always the basis for judgement.

Findings

1Deviation, CAPA, and investigation

Deviations from written test procedures are not justified to assure compliance with established specifications and standards.

2Laboratory and QC controls

Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

3Other quality system

CITY AND STATE & ZIP CODE Bothell, WA.

About this record

Extracted automatically from the document US FDA published on 2020-12-04. The source is available at the link above.

This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.

Translation and classification are automated and may differ in nuance from the source.

Juno Therapeutics, Inc. company profile — full historyAll US FDA findings US FDA documents, 2020 Go to Findings search
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