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 3007208829.
Observations3
Issue DateJuly 31, 2024
StatusNo Warning Letter
Establishment TypeManufacturer
Related Inspections4
Establishment Details
Firm
iRhythm Technologies Inc
Location
San Francisco, California, United States
FEI Number
3007208829
Establishment Type
Manufacturer
Product Type
Drugs
Issue Date
July 31, 2024
Country
United States
Inspection History, 2010 to 2024
NAI3
OAI1
NAI means No Action Indicated. OAI means Official Action Indicated.