FDA Inspection
CardioFocus, Inc.CardioFocus, Inc. – FDA Inspection, Jun 30, 2017
Record Details
This FDA Inspection record concerns CardioFocus, Inc., with an inspection on June 30, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e81f4e09-e208-4f12-a3a6-2e0940c526b7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1016613
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.198(a)Complaints
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CardioFocus, Inc.
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 11, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 7, 2015 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| November 28, 2012 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| September 23, 2011 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
Other documents for CardioFocus, Inc.
- FDA Inspection 1177544 - 2022-08-11
- FDA Inspection 928695 - 2015-05-07
- FDA Inspection 808977 - 2012-11-28
- FDA Inspection 746966 - 2011-09-23
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