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 3000204839.
Observations2
Issue DateDecember 16, 2022
StatusNo Warning Letter
Related Inspections6
Establishment Details
Firm
Terumo Cardiovascular Systems Corporation
Location
Elkton, Maryland, United States
FEI Number
3000204839
Product Type
Devices
Issue Date
December 16, 2022
Country
United States
Inspection History, 2009 to 2024
NAI4
VAI2
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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