FDA Inspection
Respicardia, Inc.Respicardia, Inc. – FDA Inspection, Feb 13, 2017
Record Details
This FDA Inspection record concerns Respicardia, Inc., with an inspection on February 13, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · c3f4214f-f8c8-4e0b-8864-4dd251dbe8a9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1006033
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 812.40Sponsors" general responsibilities
- 21 CFR 812.40Sponsors' general responsibilities
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Respicardia, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| March 22, 2024 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 4, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Respicardia, Inc.
- FDA Inspection 1235640 - 2024-03-22
- FDA Inspection 929406 - 2015-06-04
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