FDA Inspection
WalkMed Technologies, LLCWalkMed Technologies, LLC – FDA Inspection, Jun 11, 2015
Record Details
This FDA Inspection record concerns WalkMed Technologies, LLC, with an inspection on June 11, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- WalkMed Technologies, LLC
- Inspection Date
- June 11, 2015
- Product Type
- Devices
View Company Profile
ID · 644ca192-835d-47ac-a1ad-192c1c4d8907
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 931385
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.72(b)Calibration procedures - content
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.160(a)Lack of or inadequate procedures for distribution
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(f)Design verification - Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.30(g)Design validation - software validation not performed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of WalkMed Technologies, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| September 13, 2024 | VAI | Denver District Office | Compliance: Medical Devices |
| October 21, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 26, 2018 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 15, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 16, 2010 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for WalkMed Technologies, LLC
- FDA Inspection 1249204 - 2024-09-13
- FDA Inspection 1155041 - 2021-10-21
- FDA Inspection 1056975 - 2018-06-26
- FDA Inspection 874460 - 2014-04-15
- FDA Inspection 679525 - 2010-09-16
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.