FDA inspection

Terumo Cardiovascular Systems Corporation: FDA inspection ending Oct 11, 2019

FDA inspection 1111814 · No Action Indicated (NAI) · Ann Arbor, MI

Key facts

Inspection ID 1111814
Firm Terumo Cardiovascular Systems Corporation
FEI number 1828100
Address 6200 Jackson Rd
City Ann Arbor
State MI
ZIP 48103
Country United States
Fiscal year 2020
Inspection end date Oct 11, 2019
Classification No Action Indicated (NAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • None Citations
  • None Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • Yes Establishment inspection report (EIR) exists
  • 10–99 Inspections at this FEI

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA inspections

FDA inspections are classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI) or Official Action Indicated (OAI). Inspections of individual clinical investigators are not published here.

Source: U.S. Food and Drug Administration (FDA), inspection classification data

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