FDA-Inspected Site

North American Rescue LLC.

3 FDA inspections are on record for North American Rescue LLC. in Greer, United States.

483· Form 483 issued

Greer, United States · Last updated August 15, 2026

Overview

  • 3 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-03-27.

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
23 Mar 2026 – 27 Mar 2026Medical Devices & Rad Health483View 483 →
30 Jan 2020 – 31 Jan 2020Medical Devices & Rad HealthClean
15 Jun 2015 – 19 Jun 2015Medical Devices & Rad Health483View 483 →

Observations on record

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

27 Mar 2026
ISO 13485:2016 Clause 4.1.5

Inadequate monitoring and control over outsourced processes

Cited by Gamal A Norton

27 Mar 2026
ISO 13485:2016 Clause 4.1.5

Inadequate monitoring and control over outsourced processes

Cited by Gamal A Norton

19 Jun 2015
21 CFR 820.150

Lack of or inadequate procedures for storage.

Cited by Dawn M Braswell

19 Jun 2015
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Dawn M Braswell

19 Jun 2015
21 CFR 820.184

DHR - not or inadequately maintained

Cited by Dawn M Braswell

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
ISO 13485:2016 Clause 4.1.5Cited across public-safe Form 483 observations2x
21 CFR 820.150Cited across public-safe Form 483 observations1x
21 CFR 820.181Cited across public-safe Form 483 observations1x
21 CFR 820.184Cited across public-safe Form 483 observations1x
21 CFR 820.25(b)Cited across public-safe Form 483 observations1x
21 CFR 820.30(g)Cited across public-safe Form 483 observations1x
21 CFR 820.40Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind North American Rescue LLC.'s 2 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