Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3012307300.
Observations8
Issue DateApril 30, 2021
Status1 Related Warning Letter
Related Inspections3
Establishment Details
Firm
ICU Medical Inc.
Location
Minneapolis, Minnesota, United States
FEI Number
3012307300
Product Type
Devices
Issue Date
April 30, 2021
Country
United States
Inspection History, 2017 to 2023
NAI1
VAI1
OAI1
NAI means No Action Indicated. VAI means Voluntary Action Indicated. OAI means Official Action Indicated.