FDA inspection

ICU Medical Inc.: FDA inspection ending Apr 11, 2017

FDA inspection 1008934 · Voluntary Action Indicated (VAI) · Maple Grove, MN

Key facts

Inspection ID 1008934
Firm ICU Medical Inc.
FEI number 3011277191
Address 6901 E Fish Lake Rd Ste 166
City Maple Grove
State MN
ZIP 55369
Country United States
Fiscal year 2017
Inspection end date Apr 11, 2017
Classification Voluntary Action Indicated (VAI)
Project area Compliance: Devices
Product type Devices

At a glance

  • None 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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