FDA Inspection
ZOLL Circulation, Inc.ZOLL Circulation, Inc. – FDA Inspection, Nov 9, 2017
Record Details
This FDA Inspection record concerns ZOLL Circulation, Inc., with an inspection on November 9, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · da6f4b3a-caec-4882-b22e-ec48a6c6672f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031344
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.70(c)Environmental control 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 |
| February 13, 2024 | VAI | Center for Devices and Radiological Health | Project Evaluation: 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 1229961 - 2024-02-13
- FDA Inspection 890920 - 2014-08-12
- FDA Inspection 793844 - 2012-08-15
- FDA Inspection 784939 - 2012-06-21
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