Xoran Technologies, LLC – FDA Inspection, Mar 4, 2009

Record Details

This FDA Inspection record concerns Xoran Technologies, LLC, with an inspection on March 4, 2009, issued by the Center for Devices and Radiological Health, covering devices.

Company: Xoran Technologies, LLC
Inspection Date: March 4, 2009
Product Type: Devices
Office: Center for Devices and Radiological Health

View Company Profile

ID · 4f394d60-fa74-4e2d-b3ad-4133bfac2d7c

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number: 558909
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices

FDA Citations

21 CFR 820.30(b)Establish the design and development plan
21 CFR 820.40(a)Not approved or obsolete document retrieval
21 CFR 820.20(a)Management ensuring quality policy is understood
21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
21 CFR 820.30(f)Design verification procedures
21 CFR 820.30(i)Design changes - validation vs. verification
21 CFR 820.30(h)Design transfer - Lack of or inadequate procedures
21 CFR 820.70(a)(4)Approval of process
21 CFR 820.30(c)Design input approval documentation
21 CFR 820.30(d)Design output - review and approval

Showing 10 of 19 citations.

Full citation text and observation details available on the Dashboard.

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