FDA Inspection
Cardiva Medical, Inc.Cardiva Medical, Inc. – FDA Inspection, May 10, 2017
Record Details
This FDA Inspection record concerns Cardiva Medical, Inc., with an inspection on May 10, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · be7890ab-e800-406f-8eb6-3f4779213554
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1014545
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Cardiva Medical, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 21, 2023 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 14, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 25, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| November 19, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 30, 2012 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Cardiva Medical, Inc.
- FDA Inspection 1211273 - 2023-07-21
- FDA Inspection 1084157 - 2019-03-14
- FDA Inspection 871451 - 2014-03-25
- FDA Inspection 809441 - 2012-11-19
- FDA Inspection 807691 - 2012-10-30
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