Form 483

Banner Smoked Fish, Inc. Form 483, 2010-12-17

FDA issued a Form 483 to Banner Smoked Fish, Inc. on 2010-12-17 with 5 public-safe observations.

483· Form 483 issued5 observations

Banner Smoked Fish, Inc. · Brooklyn, United States · Issued December 17, 2010

Overview

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

Inspectional observations

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

17 Dec 2010
21 CFR 110.35(a)

Buildings/sanitary

Cited by Peter M Trunk

17 Dec 2010
21 CFR 123.6(b)

HACCP plan implementation

Cited by Peter M Trunk

17 Dec 2010
21 CFR 123.7(a)

Corrective action per predetermined plan

Cited by Peter M Trunk

17 Dec 2010
21 CFR 123.8(a)(2)(ii)

Calibration - adequacy

Cited by Peter M Trunk

17 Dec 2010
21 CFR 123.12(a)(2)

Importer verification

Cited by Peter M Trunk

Inspected site

BSBanner Smoked Fish, Inc.Brooklyn, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 123.12(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x
21 CFR 123.7(a)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(2)(ii)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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