FDA Inspection
ZOLL Medical CorporationZOLL Medical Corporation – FDA Inspection, Oct 25, 2017
Record Details
This FDA Inspection record concerns ZOLL Medical Corporation, with an inspection on October 25, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 789ec0f8-a95a-4b05-9a56-969d3fcc62aa
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1029757
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
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Other FDA inspections of ZOLL Medical Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 2, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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