FDA Inspection
Jazz ImagingJazz Imaging – FDA Inspection, Jul 26, 2019
Record Details
This FDA Inspection record concerns Jazz Imaging, with an inspection on July 26, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 57cbbac8-fece-4adf-8c0e-d5af1ec70450
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1097837
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(b)Rationale documented for no investigation
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.72(b)Remedial action
- 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
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Other FDA inspections of Jazz Imaging
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 1, 2026 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 24, 2022 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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