FDA Inspection
Xoran Technologies, LLCXoran Technologies, LLC – FDA Inspection, Aug 24, 2026
Record Details
This FDA Inspection record concerns Xoran Technologies, LLC, with an inspection on August 24, 2026, issued by the Detroit District Office, covering medical devices & rad health.
- Company
- Xoran Technologies, LLC
- Inspection Date
- August 24, 2026
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · e3a29517-8149-420f-8df3-71f029029659
Inspection Facts
- Inspection number
- 1332420
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- ISO 13485:2016 Clause 7.1Product realization risk management processes not documented
- ISO 13485:2016 Clause 7.3.7Design and development validation not complete prior to release of product
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
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Other FDA inspections of Xoran Technologies, LLC
7| Date | Classification | Office | Project area |
|---|---|---|---|
| July 11, 2024 | OAI | Center for Devices and Radiological Health | 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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