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Form 483

West Duluth Distribution Company Form 483, 2017-03-30

FDA issued a Form 483 to West Duluth Distribution Company on 2017-03-30 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

West Duluth Distribution Company · Cotton, United States · Issued March 30, 2017

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

30 Mar 2017
21 CFR 111.95(b)(1)

Records - established specifications

Cited by Jesse P Romenesko

30 Mar 2017
21 CFR 111.95(b)(1)

Records - established specifications

Cited by Jesse P Romenesko

Inspected site

WDWest Duluth Distribution CompanyCotton, United States

Inspection team

JPJesse P Romenesko

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.95(b)(1)Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF and 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