FDA Inspection
Cardiva Medical, Inc.Cardiva Medical, Inc. – FDA Inspection, Jul 21, 2023
Record Details
This FDA Inspection record concerns Cardiva Medical, Inc., with an inspection on July 21, 2023, issued by the Center for Devices and Radiological Health, covering devices.
- Person
- Jeffrey S. Buckser
View Company Profile
ID · ec7bae42-612c-4325-ad04-530d283ebafd
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1211273
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(e)Records of complaint investigation
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.25(b)Training records
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Other FDA inspections of Cardiva Medical, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 14, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 10, 2017 | VAI | 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 1084157 - 2019-03-14
- FDA Inspection 1014545 - 2017-05-10
- FDA Inspection 871451 - 2014-03-25
- FDA Inspection 809441 - 2012-11-19
- FDA Inspection 807691 - 2012-10-30
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