FDA inspection

ICU Medical, Inc.: FDA inspection ending Dec 11, 2015

FDA inspection 956414 · Voluntary Action Indicated (VAI) · Salt Lake City, UT

Key facts

Inspection ID 956414
Firm ICU Medical, Inc.
FEI number 1713468
Address 4455 S Atherton Dr
City Salt Lake City
State UT
ZIP 84123
Country United States
Fiscal year 2016
Inspection end date Dec 11, 2015
Classification Voluntary Action Indicated (VAI)
Project area Postmarket Assurance: Devices
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
  • 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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