FDA Inspection
ZOLL Circulation, Inc.ZOLL Circulation, Inc. – FDA Inspection, Feb 13, 2024
Record Details
This FDA Inspection record concerns ZOLL Circulation, Inc., with an inspection on February 13, 2024, issued by the Center for Devices and Radiological Health.
- Company
- ZOLL Circulation, Inc.
- Inspection Date
- February 13, 2024
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ID · 5b021cbc-0da5-4cf3-ad54-d58f5b40c8fb
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1229961
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
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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 |
| 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 |
| June 21, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for ZOLL Circulation, Inc.
- FDA Inspection 1230860 - 2024-02-13
- FDA Inspection 1031344 - 2017-11-09
- FDA Inspection 890920 - 2014-08-12
- FDA Inspection 793844 - 2012-08-15
- FDA Inspection 784939 - 2012-06-21
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