Atlas

FDA-Inspected Site

Xoran Technologies, LLC

8 FDA inspections are on record for Xoran Technologies, LLC in Ann Arbor, United States.

483· Form 483 issued

Ann Arbor, United States · Last updated July 9, 2026

Overview

  • 8 FDA inspections are on record.
  • 7 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-07-11.

At a glance

Inspections

8

Form 483s

7

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
25 Jun 2024 – 11 Jul 2024Medical Devices & Rad HealthWLView 483 →
4 Dec 2017 – 20 Dec 2017Medical Devices & Rad Health483View 483 →
8 Sep 2014 – 6 Oct 2014Medical Devices & Rad Health483View 483 →
14 May 2012Not recorded483View 483 →
29 Apr 2011Not recorded483View 483 →
14 Oct 2010Not recorded483View 483 →
4 Mar 2009Not recorded483View 483 →
26 Oct 2007Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

11 Jul 2024
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Thomas A Peter, Brian P Putz

11 Jul 2024
21 CFR 820.30(g)

Design Validation - Risk analysis not performed/inadequate

Cited by Thomas A Peter, Brian P Putz

11 Jul 2024
21 CFR 820.30(g)

Design validation - software validation not performed

Cited by Thomas A Peter, Brian P Putz

11 Jul 2024
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Thomas A Peter, Brian P Putz

11 Jul 2024
21 CFR 820.30(g)

Design Validation - Risk analysis not performed/inadequate

Cited by Thomas A Peter, Brian P Putz

Investigators

FDA investigators tied to this site in the record.

Sargum C Sood4 insp.
Thomas A Peter2 insp.
Gary D Urbiel Goldner2 insp.
Brian P Putz1 insp.
Shannon A Gregory1 insp.
Teresa K Kastner1 insp.
Amy S Graf1 insp.
Scott C Gonzalez1 insp.
Brian J Mundo1 insp.
Deanna L Lampley1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.30(g)Cited across public-safe Form 483 observations8x
21 CFR 820.100(a)Cited across public-safe Form 483 observations7x
21 CFR 1003.10(a)Cited across public-safe Form 483 observations4x
21 CFR 820.20(a)Cited across public-safe Form 483 observations4x
21 CFR 820.50Cited across public-safe Form 483 observations4x
21 CFR 1002.20(a)Cited across public-safe Form 483 observations3x
21 CFR 806.20(b)(4)Cited across public-safe Form 483 observations3x
21 CFR 820.75(a)Cited across public-safe Form 483 observations3x
21 CFR 1003.10(b)Cited across public-safe Form 483 observations2x
21 CFR 1004.1Cited across public-safe Form 483 observations2x
21 CFR 1010.2(c)Cited across public-safe Form 483 observations2x
21 CFR 1020.30(h)(4)(i)Cited across public-safe Form 483 observations2x
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x
21 CFR 820.198(b)Cited across public-safe Form 483 observations2x
21 CFR 820.198(c)Cited across public-safe Form 483 observations2x
21 CFR 820.22Cited across public-safe Form 483 observations2x
21 CFR 820.25(b)Cited across public-safe Form 483 observations2x
21 CFR 820.30(i)Cited across public-safe Form 483 observations2x
21 CFR 820.80(b)Cited across public-safe Form 483 observations2x
21 CFR 1002.10Cited across public-safe Form 483 observations1x
21 CFR 1002.13Cited across public-safe Form 483 observations1x
21 CFR 1020.30(c)Cited across public-safe Form 483 observations1x
21 CFR 1020.30(d)(1)Cited across public-safe Form 483 observations1x
21 CFR 1020.30(g)Cited across public-safe Form 483 observations1x
21 CFR 1020.30(h)(2)(i)Cited across public-safe Form 483 observations1x
21 CFR 1020.30(h)(3)(i)Cited across public-safe Form 483 observations1x
21 CFR 1020.30(h)(3)(ii)Cited across public-safe Form 483 observations1x
21 CFR 1020.30(h)(3)(v)Cited across public-safe Form 483 observations1x
21 CFR 1020.30(h)(3)(vi)Cited across public-safe Form 483 observations1x
21 CFR 1020.30(h)(3)(viii)Cited across public-safe Form 483 observations1x
21 CFR 1020.30(k)Cited across public-safe Form 483 observations1x
21 CFR 1020.33(c)(2)(i)(c)Cited across public-safe Form 483 observations1x
21 CFR 1020.33(c)(2)(ii)Cited across public-safe Form 483 observations1x
21 CFR 1020.33(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 1020.33(f)(1)Cited across public-safe Form 483 observations1x
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 806.10(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 820.120(b)Cited across public-safe Form 483 observations1x
21 CFR 820.170(a)Cited across public-safe Form 483 observations1x
21 CFR 820.181Cited across public-safe Form 483 observations1x
21 CFR 820.181(a)Cited across public-safe Form 483 observations1x
21 CFR 820.184Cited across public-safe Form 483 observations1x
21 CFR 820.184(e)Cited across public-safe Form 483 observations1x
21 CFR 820.200(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(b)Cited across public-safe Form 483 observations1x
21 CFR 820.30(c)Cited across public-safe Form 483 observations1x
21 CFR 820.30(d)Cited across public-safe Form 483 observations1x
21 CFR 820.30(e)Cited across public-safe Form 483 observations1x
21 CFR 820.30(f)Cited across public-safe Form 483 observations1x
21 CFR 820.30(h)Cited across public-safe Form 483 observations1x
21 CFR 820.40Cited across public-safe Form 483 observations1x
21 CFR 820.40(a)Cited across public-safe Form 483 observations1x
21 CFR 820.50(a)Cited across public-safe Form 483 observations1x
21 CFR 820.50(b)Cited across public-safe Form 483 observations1x
21 CFR 820.70(a)Cited across public-safe Form 483 observations1x
21 CFR 820.70(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 820.72(a)Cited across public-safe Form 483 observations1x
21 CFR 820.75(b)Cited across public-safe Form 483 observations1x
21 CFR 820.80(e)Cited across public-safe Form 483 observations1x
21 CFR 820.90(a)Cited across public-safe Form 483 observations1x
21 CFR 820.90(b)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Xoran Technologies, LLC's 7 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat