FDA inspection

Terumo Heart, Inc: FDA inspection ending Aug 16, 2010

FDA inspection 676809 · Voluntary Action Indicated (VAI) · Ann Arbor, MI

Key facts

Inspection ID 676809
Firm Terumo Heart, Inc
FEI number 3005228872
Address 6190 Jackson Rd
City Ann Arbor
State MI
ZIP 48103
Country United States
Fiscal year 2010
Inspection end date Aug 16, 2010
Classification Voluntary Action Indicated (VAI)
Project area Bioresearch Monitoring
Product type Devices

At a glance

  • 1–9 Citations
  • 1–9 Posted citations
  • No Warning letter followed
  • Yes Form FDA 483 issued
  • No Establishment inspection report (EIR) exists
  • 1–9 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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