Company
United StatesReliantHeart Inc., Houston, TX – FDA Inspections
Inspection records and compliance data for ReliantHeart Inc. in Houston, Texas. 4 FDA inspections on record (1 OAI), 1 Form 483, last inspected November 22, 2016.
Company Profile
This profile covers ReliantHeart Inc. based in Houston, Texas, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 0
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected August 6, 2009. Last inspected November 22, 2016.
Most cited issue areas
- Design plans- updated1 inspection
- Management review - defined interval, sufficient frequency1 inspection
- Management review - Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| November 22, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 995475 |
| June 30, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 884654 |
| April 30, 2010 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 666870 |
| August 6, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 611763 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
ReliantHeart Inc.
FEI Number
3003259341
Address
8965 Interchange Dr, Houston, Texas 77054, United States
Country
United States
ID: 23e79cbc-483f-462f-bc1a-6f8a0379e26e