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 1000149028.
Observations2
Issue DateSeptember 25, 2017
StatusNo Warning Letter
Related Inspections3
Establishment Details
Firm
Terumo Cardiovascular Systems Corp
Location
Ashland, Massachusetts, United States
FEI Number
1000149028
Product Type
Devices
Issue Date
September 25, 2017
Country
United States
Inspection History, 2010 to 2017
NAI1
VAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated.