Xoran Technologies, LLC – FDA Inspection, Apr 29, 2011

Record Details

This FDA Inspection record concerns Xoran Technologies, LLC, with an inspection on April 29, 2011, issued by the Center for Devices and Radiological Health, covering devices.

Company: Xoran Technologies, LLC
Inspection Date: April 29, 2011
Product Type: Devices
Office: Center for Devices and Radiological Health

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ID · 0c9622ec-c98d-496b-8640-d982119e2e75

Inspection Facts

Official Action Indicated (OAI)

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

Inspection number: 723737
FDA center: Medical Devices & Rad Health
Project area: Compliance: Devices

FDA Citations

21 CFR 1020.30(d)(1)Report of assembly submitted within 15 days
21 CFR 820.75(a)Lack of or inadequate process validation
21 CFR 1020.30(h)(3)(viii)Measurement criteria for technique factors
21 CFR 1020.30(h)(3)(v)Generator rating and duty cycle
21 CFR 1020.30(h)(4)(i)leakage technique factors, beam limiting device
21 CFR 1020.30(h)(3)(ii)Maximum line current (x-ray control + generator)
21 CFR 1020.30(h)(3)(i)Rated line voltage, range (x-ray control + generator)
21 CFR 1010.2(c)Certification not based on adequate test/testing program
21 CFR 820.198(c)Investigation of device failures
21 CFR 1020.30(k)Compliance measurements--diagnostic source assembly

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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