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 2025587.
Observations2
Issue DateMarch 30, 2016
StatusNo Warning Letter
Related Inspections7
Establishment Details
Firm
Medtronic Heart Valves Division
Location
Santa Ana, California, United States
FEI Number
2025587
Product Type
Devices
Issue Date
March 30, 2016
Country
United States
Inspection History, 2008 to 2020
NAI2
VAI5
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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