Form 483

Western Milling, LLC Form 483, 2010-10-29

FDA issued a Form 483 to Western Milling, LLC on 2010-10-29 with 3 public-safe observations.

483· Form 483 issued3 observations

Western Milling, LLC · Goshen, United States · Issued October 29, 2010

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

29 Oct 2010
21 CFR 225.142

Adequate procedures for Type A and Type B articles

Cited by Thomas W Gordon, Elva M Ibarra

29 Oct 2010
21 CFR 225.158

Investigation and corrective action

Cited by Thomas W Gordon, Elva M Ibarra

29 Oct 2010
21 CFR 225.165

Establishment and use of adequate procedures

Cited by Thomas W Gordon, Elva M Ibarra

Inspected site

WMWestern Milling, LLCGoshen, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 225.142Cited across public-safe Form 483 observations1x
21 CFR 225.158Cited across public-safe Form 483 observations1x
21 CFR 225.165Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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