iRhythm Technologies, Inc.

Form 483

Cypress, California, United StatesFEI 3021769057Issued May 24, 2013

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 3021769057.

Observations1

Issue DateMay 24, 2013

Status1 Related Warning Letter

Related Inspections3

Establishment Details

Firm: iRhythm Technologies, Inc.
Location: Cypress, California, United States
FEI Number: 3021769057
Product Type: Devices
Issue Date: May 24, 2013
Country: United States

Inspection History, 2013 to 2022

NAI1

VAI1

OAI1

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

iRhythm Technologies, Inc. FDA Form 483, Cypress, California, May 24, 2013