Xoran Technologies, LLC – FDA Inspection, May 14, 2012

Record Details

This FDA Inspection record concerns Xoran Technologies, LLC, with an inspection on May 14, 2012, issued by the Center for Devices and Radiological Health, covering devices.

Company: Xoran Technologies, LLC
Inspection Date: May 14, 2012
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · a316af35-a5f7-4ca4-8bff-954099394471

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 779682
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 820.80(e)Documentation
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 1010.2(c)Certification not based on adequate test/testing program
21 CFR 820.198(c)Investigation of device failures
21 CFR 820.40Lack of procedures, or not maintained
21 CFR 1004.1CAP not submitted
21 CFR 820.170(a)Lack of or inadequate instructions
21 CFR 820.20(a)Management ensuring quality policy is understood
21 CFR 820.25(b)Training records
21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures

Showing 10 of 19 citations.

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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
April 29, 2011	OAI	Center for Devices and Radiological Health	Compliance: Devices