Atlas

Form 483

Duwell Fish Co., Inc. Form 483, 2009-10-02

FDA issued a Form 483 to Duwell Fish Co., Inc. on 2009-10-02 with 3 public-safe observations.

483· Form 483 issued3 observations

Duwell Fish Co., Inc. · Chicago, United States · Issued October 2, 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.

2 Oct 2009
21 CFR 110.20(a)(1)

Harborage areas

Cited by Samuel W Labinjo, Bradley J Maunder

2 Oct 2009
21 CFR 123.8(d)

Verification - recordkeeping

Cited by Samuel W Labinjo, Bradley J Maunder

2 Oct 2009
21 CFR 123.11(b)

Sanitation monitoring

Cited by Samuel W Labinjo, Bradley J Maunder

Inspected site

DFDuwell Fish Co., Inc.Chicago, United States

Inspection team

SWSamuel W Labinjo
BJBradley J Maunder

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.8(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