FDA Inspection
Xoran Technologies, LLCXoran Technologies, LLC – FDA Inspection, Jul 11, 2024
Record Details
This FDA Inspection record concerns Xoran Technologies, LLC, with an inspection on July 11, 2024, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 069d72cc-a705-4739-9e16-61bf6e88f98b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1243723
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Enforcement
- Warning Letter
FDA Citations
4- 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 820.30(g)Design validation - software validation not performed
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Xoran Technologies, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| August 24, 2026 | Not classified | Detroit District Office | Compliance: Devices |
| December 20, 2017 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| October 6, 2014 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 14, 2012 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 29, 2011 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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