FDA-Inspected Site

OBS SMOKED & DISTRIBUTION LLC

11 FDA inspections are on record for OBS SMOKED & DISTRIBUTION LLC in Helena, United States.

483· Form 483 issued

Helena, United States · Last updated July 9, 2026

Overview

  • 11 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-08-14.

At a glance

Inspections

11

Form 483s

6

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
12 Aug 2025 – 14 Aug 2025Foods & Cosmetics483On file
30 Jun 2022 – 25 Jul 2022Foods & Cosmetics483View 483 →
19 Oct 2017Foods & Cosmetics483View 483 →
4 May 2015 – 5 May 2015Foods & CosmeticsClean
17 Nov 2011Not recorded483On file
15 Jul 2010Not recorded483View 483 →
16 May 2008Not recorded483On file
18 Sep 2003Not recordedClean
12 Jul 2001Not recordedClean
8 Nov 2000Not recordedClean
1 May 2000Not recordedClean

Observations on record

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

25 Jul 2022
21 CFR 123.6(b)

HACCP plan implementation

Cited by Sunny R Muir

25 Jul 2022
21 CFR 123.6(c)(7)

Records values/observations

Cited by Sunny R Muir

25 Jul 2022
21 CFR 123.7(a)

Corrective action per predetermined plan

Cited by Sunny R Muir

25 Jul 2022
21 CFR 123.8(a)

Verification - reviewers qualifications

Cited by Sunny R Muir

25 Jul 2022
21 CFR 123.8(a)(2)(ii)

Calibration - adequacy

Cited by Sunny R Muir

Investigators

FDA investigators tied to this site in the record.

Erica R Mahone1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 123.11(b)Cited across public-safe Form 483 observations2x
21 CFR 123.6(b)Cited across public-safe Form 483 observations2x
21 CFR 123.8(a)(2)(ii)Cited across public-safe Form 483 observations2x
21 CFR 117.4Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(7)Cited across public-safe Form 483 observations1x
21 CFR 123.6(d)Cited across public-safe Form 483 observations1x
21 CFR 123.7(a)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind OBS SMOKED & DISTRIBUTION LLC's 6 Form 483s

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