FDA Inspection
ZOLL Medical CorporationZOLL Medical Corporation – FDA Inspection, Jul 11, 2014
Record Details
This FDA Inspection record concerns ZOLL Medical Corporation, with an inspection on July 11, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ZOLL Medical Corporation
- Inspection Date
- July 11, 2014
- Product Type
- Devices
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ID · 7a66d3c7-5762-4fe8-b73e-8853475f8e22
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 885657
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of ZOLL Medical Corporation
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 25, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 2, 2011 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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