FDA-Inspected Site

UREN NORTH AMERICA LLC

3 FDA inspections are on record for UREN NORTH AMERICA LLC in Waynesville, United States.

Clean· No action indicated

Waynesville, United States · Last updated July 9, 2026

Overview

  • 3 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2024-09-30.

At a glance

Inspections

3

Form 483s

1

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
27 Jun 2024 – 30 Sep 2024Foods & CosmeticsClean
24 Jan 2022 – 10 Feb 2022Foods & CosmeticsClean
25 Jan 2018 – 29 Jan 2018Foods & Cosmetics483View 483 →

Observations on record

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

29 Jan 2018
21 CFR 1.502(a)

Develop FSVP

Cited by Michael F Mccoy

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 1.502(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind UREN NORTH AMERICA LLC's 1 Form 483

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