FacilityLedger

Device establishmentActive, RegisteredFDA warning letter on file

Xoran Technologies, LLC

Xoran Technologies, LLC is an FDA-registered device establishment (FEI 3004198450) located in Ann Arbor, Michigan. The facility is active, registered. Its most recent FDA inspection on record (2024-07-11) was classified OAI. FDA has issued 1 warning letter(s) to this facility.

FDA warning letter

Dec 9, 2024
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Read the letter on FDA.gov ›

A warning letter is FDA's formal notice of significant violations that require prompt correction. It can hold up product approvals, trigger import alerts, and put supply agreements at risk until the issues are resolved and FDA closes it out.

Recalls (1)

Jul 27, 2010 Class II
The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ¿ 3 kVp. These 18 complaints received include dose rates both on the high and low end of
TerminatedView source data ›

Recall data from openFDA enforcement reports (FDA Recall Enterprise System).

Establishment record

FEI Number
3004198450
Address
5210 South State Road, Ann Arbor, Michigan
Establishment type
Device establishment
Products / operations
Radiology, Remanufacture Medical Device, Complaint File Establishment per 21 CFR 820.198, Manufacture Medical Device
Registration status
Active, Registered

Verify this record in FDA source data ›

Inspection history

Inspections on file
Jul 11, 2024 · Official Action Indicated (OAI)
Jul 11, 2024 · No Action Indicated (NAI)
Dec 20, 2017 · No Action Indicated (NAI)
Dec 20, 2017 · Voluntary Action Indicated (VAI)
Oct 6, 2014 · Voluntary Action Indicated (VAI)
May 14, 2012 · Official Action Indicated (OAI)
Apr 29, 2011 · Official Action Indicated (OAI)
Oct 14, 2010 · Official Action Indicated (OAI)
Mar 4, 2009 · Voluntary Action Indicated (VAI)
Form 483 observations
Jul 11, 2024, 4 observations: Purchasing controls, Lack of or inadequate procedures; Lack of or inadequate complaint procedures; Design Validation - Risk analysis not performed/inadequate
Dec 20, 2017, 2 observations: Lack of or inadequate procedures; Justification for not reporting
Oct 6, 2014, 9 observations: FDA not notified of defect or noncompliance; Providing adequate assembly information; Failure to report
May 14, 2012, 19 observations: Servicing - Lack of or inadequate procedures; Lack of or inadequate instructions; Lack of or inadequate procedures
Apr 29, 2011, 31 observations: Fixed technique factors--max deviation from nominal; Measurement criteria for technique factors; Failure to submit, distinct marking
Oct 14, 2010, 8 observations: Lack of or inadequate procedures; Review and evaluation for investigation; Management ensuring quality policy is understood

FDA record timeline

Warning letter
CGMP/QSR/Medical Devices/Adulterated/Misbranded
Source ›
FDA inspection
OAI classification
FDA inspection
NAI classification
Form 483
4 observations
FDA inspection
NAI classification
FDA inspection
VAI classification
Form 483
2 observations
FDA inspection
VAI classification
Form 483
9 observations
FDA inspection
OAI classification
Form 483
19 observations
FDA inspection
OAI classification
Form 483
31 observations
FDA inspection
OAI classification
Form 483
8 observations
Recall
Class II — The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ¿ 3 kVp. These 18 complaints received include dose rates both on the high and low end of
Source ›

Combined chronology of the public records shown on this page. FDA coverage varies by dataset and year.

Questions

Is Xoran Technologies, LLC registered with the FDA?

Yes. Xoran Technologies, LLC is an FDA-registered device establishment (FEI 3004198450) in Ann Arbor, Michigan. Its current registration status is Active, Registered.

Has Xoran Technologies, LLC received an FDA warning letter?

Yes. FDA issued a warning letter to Xoran Technologies, LLC; the most recent is dated Dec 9, 2024 (CGMP/QSR/Medical Devices/Adulterated/Misbranded).

What does Xoran Technologies, LLC do?

Xoran Technologies, LLC's FDA-registered operations are: Radiology, Remanufacture Medical Device, Complaint File Establishment per 21 CFR 820.198, Manufacture Medical Device.

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Source: FDA public data · status as of 2026-08-22

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