FDA Inspection
WalkMed Technologies, LLCWalkMed Technologies, LLC – FDA Inspection, Sep 16, 2010
Record Details
This FDA Inspection record concerns WalkMed Technologies, LLC, with an inspection on September 16, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- WalkMed Technologies, LLC
- Inspection Date
- September 16, 2010
- Product Type
- Devices
View Company Profile
ID · afe1247b-07aa-451c-934a-43c93bc72aa7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 679525
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
5- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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 |
| June 11, 2015 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 15, 2014 | VAI | Center for Devices and Radiological Health | Compliance: 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 931385 - 2015-06-11
- FDA Inspection 874460 - 2014-04-15
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