FDA Inspection
ReliantHeart Inc.ReliantHeart Inc. – FDA Inspection, Aug 6, 2009
Record Details
This FDA Inspection record concerns ReliantHeart Inc., with an inspection on August 6, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ReliantHeart Inc.
- Inspection Date
- August 6, 2009
- Product Type
- Devices
View Company Profile
ID · 26fe0fa5-b894-44b9-85da-f572b0a84f52
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 611763
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of ReliantHeart Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| November 22, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| 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 |
Other documents for ReliantHeart Inc.
- FDA Inspection 995475 - 2016-11-22
- FDA Inspection 884654 - 2014-06-30
- FDA Inspection 666870 - 2010-04-30
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