FDA Inspection
WalkMed Technologies, LLCWalkMed Technologies, LLC – FDA Inspection, Sep 13, 2024
Record Details
This FDA Inspection record concerns WalkMed Technologies, LLC, with an inspection on September 13, 2024, issued by the Denver District Office, covering medical devices & rad health.
- Company
- WalkMed Technologies, LLC
- Inspection Date
- September 13, 2024
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · 73c7794e-6de2-44d0-898d-1480c2c14c3f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1249204
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of WalkMed Technologies, LLC
5| Date | Classification | Office | Project area |
|---|---|---|---|
| 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 |
| June 11, 2015 | OAI | Center for Devices and Radiological Health | Compliance: 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 1155041 - 2021-10-21
- FDA Inspection 1056975 - 2018-06-26
- FDA Inspection 931385 - 2015-06-11
- FDA Inspection 874460 - 2014-04-15
- FDA Inspection 679525 - 2010-09-16
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