FDA Inspection
Zoll Medical CorporationZoll Medical Corporation – FDA Inspection, Jun 13, 2022
Record Details
This FDA Inspection record concerns Zoll Medical Corporation, with an inspection on June 13, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Zoll Medical Corporation
- Inspection Date
- June 13, 2022
- Product Type
- Devices
View Company Profile
ID · 99a916ec-e494-466f-ab11-0289f8ef3708
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1171958
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Zoll Medical Corporation
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2024 | Not classified | Minneapolis District Office | Compliance: Medical Devices |
| November 10, 2016 | VAI | Minneapolis District Office | Project Evaluation: Devices |
| September 18, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| January 11, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| December 17, 2010 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Zoll Medical Corporation
- FDA Inspection 1229838 - 2024-09-13
- FDA Inspection 992925 - 2016-11-10
- FDA Inspection 800735 - 2012-09-18
- FDA Inspection 712206 - 2011-01-11
- FDA Inspection 683406 - 2010-12-17
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