Atlas

FDA-Inspected Site

Reflexonic, LLC

3 FDA inspections are on record for Reflexonic, LLC in Mc Lean, United States.

483· Form 483 issued

Mc Lean, United States · Last updated July 10, 2026

Overview

  • 3 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-09-24.

At a glance

Inspections

3

Form 483s

3

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
8 Sep 2025 – 24 Sep 2025Medical Devices & Rad Health483View 483 →
15 Oct 2018 – 17 Oct 2018Medical Devices & Rad Health483View 483 →
4 Apr 2016 – 19 Apr 2016Medical Devices & Rad Health483View 483 →

Observations on record

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

24 Sep 2025
21 CFR 801.20(a)

Label to bear a unique device identifier

Cited by Katelyn A Staub-Zamperini, Heath A Gerber

24 Sep 2025
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Katelyn A Staub-Zamperini, Heath A Gerber

24 Sep 2025
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Katelyn A Staub-Zamperini, Heath A Gerber

24 Sep 2025
21 CFR 820.198(a)

Complaints

Cited by Katelyn A Staub-Zamperini, Heath A Gerber

24 Sep 2025
21 CFR 820.20(b)

Lack of or inadequate organizational structure

Cited by Katelyn A Staub-Zamperini, Heath A Gerber

Investigators

FDA investigators tied to this site in the record.

James M Simpson2 insp.
Katelyn A Staub-Zamperini1 insp.
Heath A Gerber1 insp.
Jacob M Dyer1 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 observations6x
21 CFR 820.100(a)Cited across public-safe Form 483 observations5x
21 CFR 820.198(c)Cited across public-safe Form 483 observations4x
21 CFR 820.25(b)Cited across public-safe Form 483 observations4x
21 CFR 820.90(a)Cited across public-safe Form 483 observations4x
21 CFR 820.181Cited across public-safe Form 483 observations3x
21 CFR 820.198(a)Cited across public-safe Form 483 observations3x
21 CFR 820.50Cited across public-safe Form 483 observations3x
21 CFR 803.50(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 820.160(b)Cited across public-safe Form 483 observations2x
21 CFR 820.200(a)Cited across public-safe Form 483 observations2x
21 CFR 820.30(c)Cited across public-safe Form 483 observations2x
21 CFR 820.30(f)Cited across public-safe Form 483 observations2x
21 CFR 820.30(i)Cited across public-safe Form 483 observations2x
21 CFR 820.40Cited across public-safe Form 483 observations2x
21 CFR 820.70(i)Cited across public-safe Form 483 observations2x
21 CFR 820.80(d)Cited across public-safe Form 483 observations2x
21 CFR 801.20(a)Cited across public-safe Form 483 observations1x
21 CFR 820.20(b)Cited across public-safe Form 483 observations1x
21 CFR 820.20(c)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
21 CFR 830.300(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Reflexonic, LLC'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