Source: FDA, document on file. FDA released the Form 483 itself. The document linked above is our copy of FDA's file, stored by us so the link cannot break, and FDA's own copy is linked beside it. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3021769057.
Observations4
Issue DateAugust 12, 2022
Status1 Related Warning Letter
Establishment TypeMedical Device Manufacturer
Related Inspections3
Establishment Details
Firm
iRhythm Technologies
Location
Cypress, California, United States
FEI Number
3021769057
Establishment Type
Medical Device Manufacturer
Product Type
Devices
Issue Date
August 12, 2022
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.
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