FDA-Inspected Site

Advanced Research Medical, LLC

2 FDA inspections are on record for Advanced Research Medical, LLC in Burnsville, United States.

483· Form 483 issued

Burnsville, United States · Last updated August 15, 2026

Overview

  • 2 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-10-01.

At a glance

Inspections

2

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
23 Sep 2025 – 1 Oct 2025Medical Devices & Rad Health483View 483 →
6 Dec 2022 – 20 Dec 2022Medical Devices & Rad Health483View 483 →

Observations on record

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

1 Oct 2025
21 CFR 803.50(a)(2)

Individual Report of Malfunction

Cited by Benjamin W Anderson

1 Oct 2025
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Benjamin W Anderson

1 Oct 2025
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Benjamin W Anderson

1 Oct 2025
21 CFR 820.30(g)

Design Validation - Risk analysis not performed/inadequate

Cited by Benjamin W Anderson

1 Oct 2025
21 CFR 820.70(a)

Process control procedures, Lack of or inadequate procedures

Cited by Benjamin W Anderson

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 803.50(a)(2)Cited across public-safe Form 483 observations2x
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.30(g)Cited across public-safe Form 483 observations2x
21 CFR 820.75(a)Cited across public-safe Form 483 observations2x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.20(c)Cited across public-safe Form 483 observations1x
21 CFR 820.70(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Advanced Research Medical, LLC'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