FDA-Inspected Site

AR Fabricating

3 FDA inspections are on record for AR Fabricating in Georgetown, United States.

483· Form 483 issued

Georgetown, United States · Last updated July 10, 2026

Overview

  • 3 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-02-11.

At a glance

Inspections

3

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
9 Feb 2026 – 11 Feb 2026Medical Devices & Rad Health483View 483 →
19 Mar 2018 – 22 Mar 2018Medical Devices & Rad Health483On file
27 Jan 2014 – 30 Jan 2014Medical Devices & Rad HealthClean

Observations on record

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

11 Feb 2026
ISO 13485:2016 Clause 7.4.1

Criteria for the evaluation and selection of suppliers not established

Cited by Katlin N Stubbs

11 Feb 2026
ISO 13485:2016 Clause 7.5.1

Production controls not adequate

Cited by Katlin N Stubbs

11 Feb 2026
ISO 13485:2016 Clause 7.5.6

Process for production and service provision not validated

Cited by Katlin N Stubbs

Investigators

FDA investigators tied to this site in the record.

State Agency1 insp.
CntrctMntr YoungJD1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
ISO 13485:2016 Clause 7.4.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.5.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.5.6Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind AR Fabricating's 2 Form 483s

Source PDFs 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