FDA Inspection
Xoran Technologies, LLCXoran Technologies, LLC – FDA Inspection, Dec 20, 2017
Record Details
This FDA Inspection record concerns Xoran Technologies, LLC, with an inspection on December 20, 2017, issued by the Center for Devices and Radiological Health, covering devices.
- People
- Sargum C. Morgan
- Shannon A. Gregory (Investigator)
- Teresa K. Kastner
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ID · ebf8cade-97c1-4473-9bc6-ad1a344a48ae
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1035619
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 806.20(b)(4)Justification for not reporting
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Xoran Technologies, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| August 24, 2026 | Not classified | Detroit District Office | Compliance: Devices |
| July 11, 2024 | OAI | Center for Devices and Radiological Health | Compliance: 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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