Xoran Technologies, LLC – FDA Inspection, Oct 6, 2014

Record Details

This FDA Inspection record concerns Xoran Technologies, LLC, with an inspection on October 6, 2014, issued by the Center for Devices and Radiological Health, covering devices.

Company: Xoran Technologies, LLC
Inspection Date: October 6, 2014
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · ae14c6ad-be14-4d4c-a2cd-5913f5966ca2

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number: 899086
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 1020.30(g)Providing adequate assembly information
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.198(a)Lack of or inadequate complaint procedures
21 CFR 820.25(b)Training - Lack of or inadequate procedures
21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
21 CFR 1002.20(a)Failure to report
21 CFR 1003.10(a)FDA not notified of defect or noncompliance

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Other FDA inspections of Xoran Technologies, LLC

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
December 20, 2017	VAI	Center for Devices and Radiological Health	Postmarket Assurance: 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