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 3003761017.
Observations2
Issue DateAugust 18, 2017
Status1 Related Warning Letter
Related Inspections5
Establishment Details
Firm
SynCardia Systems LLC
Location
Tucson, Arizona, United States
FEI Number
3003761017
Product Type
Devices
Issue Date
August 18, 2017
Country
United States
Inspection History, 2011 to 2018
NAI2
VAI3
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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