FDA Inspection
Jazz ImagingJazz Imaging – FDA Inspection, Oct 1, 2026
Record Details
This FDA Inspection record concerns Jazz Imaging, with an inspection on October 1, 2026, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.
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ID · 75f6f604-85a3-4041-b43c-193c36942bc6
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1338726
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- ISO 13485:2016 Clause 8.5.1Production controls not adequate
- ISO 13485:2016 Clause 6.2(a)Process(es) for personnel competence, training and awareness not documented
- 21 CFR 820.35(a)Records of complaint investigations do not include required information
- 21 CFR 803.17Lack of Written MDR Procedures
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
- ISO 13485:2016 Clause 6.2Process(es) for personnel competence, training and awareness not documented
- ISO 13485:2016 Clause 7.5.1Production controls not adequate
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Other FDA inspections of Jazz Imaging
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 24, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| July 26, 2019 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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