Company
United StatesiRhythm Technologies, Inc., Cypress, CA – FDA Inspections
Inspection records and compliance data for iRhythm Technologies, Inc. in Cypress, California. 5 FDA inspections on record (1 OAI), 1 Form 483, last inspected July 31, 2024.
Company Profile
This profile covers iRhythm Technologies, Inc. based in Cypress, California, United States.
FDA Inspection History
- FDA inspections
- 5
- OAI
- 1
- VAI
- 1
- NAI
- 1
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected May 24, 2013. Last inspected July 31, 2024.
Most cited issue areas
- Lack of or inadequate complaint procedures2 inspections
- DHR - not or inadequately maintained1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (5)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 31, 2024 | Not classified | Medical Devices & Rad Health · Compliance: Devices | 1245153 |
| August 12, 2022 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1178260 |
| October 30, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1077749 |
| August 3, 2017 | Not classified | Medical Devices & Rad Health | 1025588 |
| May 24, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 833835 |
FDA documents
Form 483s (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
iRhythm Technologies, Inc.
FEI Number
3021769057
Address
6550 Katella Ave Ste 200, Cypress, California 90630, United States
Country
United States
ID: 22726654-c3a7-4b3b-9cc8-9d0032796ab3