Xoran Technologies, LLC – FDA Inspection, Oct 14, 2010

Record Details

This FDA Inspection record concerns Xoran Technologies, LLC, with an inspection on October 14, 2010, issued by the Center for Devices and Radiological Health, covering devices.

Company: Xoran Technologies, LLC
Inspection Date: October 14, 2010
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 9017b00e-bdb5-417e-802d-f882c78fda38

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number: 695219
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 806.10(a)(1)Report of risk to health
21 CFR 820.20(a)Management ensuring quality policy is understood
21 CFR 820.198(b)Review and evaluation for investigation
21 CFR 820.100(a)Lack of or inadequate procedures
21 CFR 820.22Quality audits - Lack of or inadequate procedures
21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
21 CFR 803.17Lack of Written MDR Procedures
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
October 6, 2014	VAI	Center for Devices and Radiological Health	Compliance: Devices
May 14, 2012	OAI	Center for Devices and Radiological Health	Compliance: Devices