GE Medical Systems, LLC

Form 483

Waukesha, Wisconsin, United StatesFEI 2126677Issued February 28, 2014

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 2126677.

Observations1

Issue DateFebruary 28, 2014

StatusNo Warning Letter

Related Inspections7

Establishment Details

Firm: GE Medical Systems, LLC
Location: Waukesha, Wisconsin, United States
FEI Number: 2126677
Product Type: Devices
Issue Date: February 28, 2014
Country: United States

Inspection History, 2010 to 2022

NAI4

VAI3

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.

GE Medical Systems, LLC FDA Form 483, Waukesha, Wisconsin, February 28, 2014