Form 483

The Dutch Kettle, LLC Form 483, 2009-07-27

FDA issued a Form 483 to The Dutch Kettle, LLC on 2009-07-27 with 3 public-safe observations.

483· Form 483 issued3 observations

The Dutch Kettle, LLC · Bremen, United States · Issued July 27, 2009

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.

27 Jul 2009
21 CFR 108.25(c)(2)

Process filing

Cited by Brian M Campbell, Eric S Pittman

27 Jul 2009
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Brian M Campbell, Eric S Pittman

27 Jul 2009
21 CFR 114.100(d)

Product distribution

Cited by Brian M Campbell, Eric S Pittman

Inspected site

TDThe Dutch Kettle, LLCBremen, United States

Inspection team

BMBrian M Campbell

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 108.25(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 114.100(d)Cited 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