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 1218444.
Observations1
Issue DateApril 03, 2017
StatusNo Warning Letter
Related Inspections5
Establishment Details
Firm
Thoratec Corporation
Location
Burlington, Massachusetts, United States
FEI Number
1218444
Product Type
Devices
Issue Date
April 03, 2017
Country
United States
Inspection History, 2009 to 2018
NAI2
VAI3
NAI means No Action Indicated. VAI means Voluntary Action Indicated.