Company
United StatesWalkMed Technologies, LLC, Aurora, CO – FDA Inspections
Inspection records and compliance data for WalkMed Technologies, LLC in Aurora, Colorado. 6 FDA inspections on record (1 OAI), 2 Form 483s, last inspected September 13, 2024.
Company Profile
This profile covers WalkMed Technologies, LLC based in Aurora, Colorado, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 1
- VAI
- 3
- NAI
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected September 16, 2010. Last inspected September 13, 2024.
Most cited issue areas
- Design Validation - Risk analysis not performed/inadequate3 inspections
- Individual Report of Malfunction3 inspections
- Investigation of device failures2 inspections
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 13, 2024 | VAI | Medical Devices & Rad Health · Compliance: Medical Devices | 1249204 |
| October 21, 2021 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1155041 |
| June 26, 2018 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1056975 |
| June 11, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 931385 |
| April 15, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 874460 |
| September 16, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 679525 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
WalkMed Technologies, LLC
FEI Number
3000204189
Address
1390 S Potomac St Ste 110, Aurora, Colorado 80012, United States
Country
United States
ID: 58a53c87-aaa8-4d7e-846e-8ec2f71234ef