Company
United StatesiRhythm Technologies Inc, San Francisco, CA – FDA Inspections
Inspection records and compliance data for iRhythm Technologies Inc in San Francisco, California. 4 FDA inspections on record (1 OAI), last inspected July 31, 2024.
Company Profile
This profile covers iRhythm Technologies Inc based in San Francisco, California, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 0
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected December 14, 2010. Last inspected July 31, 2024.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate1 inspection
- Individual Report of Malfunction1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 31, 2024 | OAI | Medical Devices & Rad Health · Compliance: Devices | 1245190 |
| June 29, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 976467 |
| February 28, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 820317 |
| December 14, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 701878 |
FDA documents
Form 483s (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
iRhythm Technologies Inc
FEI Number
3007208829
Address
699 8th St Ste 600, San Francisco, California 94103, United States
Country
United States
ID: fb230c01-1845-46a2-82fa-5eda280fcc0c