Atlas

FDA-Inspected Site

ARJ Medical, Inc.

7 FDA inspections are on record for ARJ Medical, Inc. in Oldsmar, United States.

Clean· No action indicated

Oldsmar, United States · Last updated July 10, 2026

Overview

  • 7 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2021-10-19.

At a glance

Inspections

7

Form 483s

3

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
19 Oct 2021Medical Devices & Rad HealthClean
7 Jan 2020 – 10 Jan 2020Medical Devices & Rad HealthClean
15 Apr 2019 – 19 Apr 2019Medical Devices & Rad HealthClean
21 Jul 2015Medical Devices & Rad HealthClean
9 Dec 2011Not recorded483View 483 →
14 Feb 2011Not recorded483View 483 →
9 Mar 2010Not recordedWLView 483 →

Observations on record

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

9 Dec 2011
21 CFR 820.30(j)

Design history file

Cited by Joshua J Silvestri

9 Dec 2011
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Joshua J Silvestri

9 Dec 2011
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Joshua J Silvestri

9 Dec 2011
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Joshua J Silvestri

14 Feb 2011
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Joshua J Silvestri, Jennifer A Robinson

Investigators

FDA investigators tied to this site in the record.

Joshua J Silvestri3 insp.
Emma R Schaefer1 insp.
Jennifer S Ness1 insp.
Ladislav Kermet1 insp.
Melanie W Pishnery1 insp.
Melanie G Warzala1 insp.
Jennifer A Robinson1 insp.
Melinda B Lewis1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.198(a)Cited across public-safe Form 483 observations4x
21 CFR 820.100(a)Cited across public-safe Form 483 observations3x
21 CFR 820.50Cited across public-safe Form 483 observations3x
21 CFR 820.30(j)Cited across public-safe Form 483 observations2x
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.181Cited across public-safe Form 483 observations1x
21 CFR 820.20(a)Cited across public-safe Form 483 observations1x
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.30(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind ARJ Medical, Inc.'s 3 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