Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3003259341.
Observations1
Issue DateNovember 22, 2016
StatusNo Warning Letter
Related Inspections4
Establishment Details
Firm
ReliantHeart Inc.
Location
Houston, Texas, United States
FEI Number
3003259341
Product Type
Devices
Issue Date
November 22, 2016
Country
United States
Inspection History, 2009 to 2016
NAI2
VAI1
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.