FDA Inspection
ZOLL Circulation, Inc.ZOLL Circulation, Inc. – FDA Inspection, Dec 14, 2010
Record Details
This FDA Inspection record concerns ZOLL Circulation, Inc., with an inspection on December 14, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ZOLL Circulation, Inc.
- Inspection Date
- December 14, 2010
- Product Type
- Devices
View Company Profile
ID · de6be58a-3d51-4bc3-a7f6-eb110675413e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 700722
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 806.20(a)Records not kept
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Other FDA inspections of ZOLL Circulation, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 13, 2024 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 13, 2024 | VAI | Center for Devices and Radiological Health | Project Evaluation: Devices |
| November 9, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 12, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 15, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ZOLL Circulation, Inc.
- FDA Inspection 1230860 - 2024-02-13
- FDA Inspection 1229961 - 2024-02-13
- FDA Inspection 1031344 - 2017-11-09
- FDA Inspection 890920 - 2014-08-12
- FDA Inspection 793844 - 2012-08-15
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