FDA Inspection
ReliantHeart Inc.ReliantHeart Inc. – FDA Inspection, Nov 22, 2016
Record Details
This FDA Inspection record concerns ReliantHeart Inc., with an inspection on November 22, 2016, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · cd68a2fc-bf50-483c-a9c9-d78c83b5058c
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 995475
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.30(b)Design plans- updated
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ReliantHeart Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| June 30, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 30, 2010 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| August 6, 2009 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ReliantHeart Inc.
- FDA Inspection 884654 - 2014-06-30
- FDA Inspection 666870 - 2010-04-30
- FDA Inspection 611763 - 2009-08-06
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.