Atlas

Form 483

OBS SMOKED & DISTRIBUTION LLC Form 483, 2010-07-15

FDA issued a Form 483 to OBS SMOKED & DISTRIBUTION LLC on 2010-07-15 with 2 public-safe observations.

483· Form 483 issued2 observations

OBS SMOKED & DISTRIBUTION LLC · Helena, United States · Issued July 15, 2010

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

15 Jul 2010
21 CFR 123.6(b)

HACCP plan implementation

Cited by Abby M Miller, Leya A Grosch

15 Jul 2010
21 CFR 123.11(b)

Sanitation monitoring

Cited by Abby M Miller, Leya A Grosch

Inspected site

OSOBS SMOKED & DISTRIBUTION LLCHelena, United States

Inspection team

AMAbby M Miller
LALeya A Grosch

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

Every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere