ICU Medical

Form 483

Dublin, Ohio, United StatesFEI 1526863Issued March 02, 2015

View FDA's Record for This Firm

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 1526863.

Observations2

Issue DateMarch 02, 2015

Status1 Related Warning Letter

Related Inspections3

Establishment Details

Firm: ICU Medical
Location: Dublin, Ohio, United States
FEI Number: 1526863
Product Type: Devices
Issue Date: March 02, 2015
Country: United States

Inspection History, 2011 to 2016

NAI1

VAI2

NAI means No Action Indicated. VAI means Voluntary Action Indicated.

Act on This Form 483

FDA Inspection ReadinessSee how your operations would hold up to the same scrutiny.CAPA & InvestigationsScore how you would investigate and close findings like these.Talk to a SpecialistWalk through these observations with a ComplianceQuest expert.

ICU Medical FDA Form 483, Dublin, Ohio, March 2, 2015