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 3003289183.
Observations3
Issue DateJune 10, 2011
StatusNo Warning Letter
Related Inspections6
Establishment Details
Firm
Premier Heart, LLC
Location
Port Washington, New York, United States
FEI Number
3003289183
Product Type
Devices
Issue Date
June 10, 2011
Country
United States
Inspection History, 2011 to 2024
NAI3
VAI3
NAI means No Action Indicated. VAI means Voluntary Action Indicated.