Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 1828100.
Observations8
Issue DateJuly 11, 2015
StatusNo Warning Letter
Establishment TypeMedical Device Manufacturer
Related Inspections10
Establishment Details
Firm
Terumo Cardiovascular Systems Corporation
Location
Ann Arbor, Michigan, United States
FEI Number
1828100
Establishment Type
Medical Device Manufacturer
Product Type
Devices
Issue Date
July 11, 2015
Country
United States
Inspection History, 2010 to 2021
NAI7
OAI3
NAI means No Action Indicated. OAI means Official Action Indicated.
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