Form 483

Banner Smoked Fish, Inc. Form 483, 2020-01-02

FDA issued a Form 483 to Banner Smoked Fish, Inc. on 2020-01-02 with 7 public-safe observations.

483· Form 483 issuedFoods & Cosmetics7 observations

Banner Smoked Fish, Inc. · Brooklyn, United States · Issued January 2, 2020

Overview

  • 7 public-safe observations are available for this inspection.
  • 7 structured CFR citations are represented.
  • 4 investigators are tied to this Form 483.

Inspectional observations

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

2 Jan 2020
21 CFR 110.20(b)(1)

Sufficient space

Cited by Ashley Polizzotto, Peter M Trunk, Morgan J Matthews, Ashley Defilippis

2 Jan 2020
21 CFR 117.20(b)

Plant Construction and Design

Cited by Ashley Polizzotto, Peter M Trunk, Morgan J Matthews, Ashley Defilippis

2 Jan 2020
21 CFR 117.35(a)

Sanitary Operations - Plant Maintenance

Cited by Ashley Polizzotto, Peter M Trunk, Morgan J Matthews, Ashley Defilippis

2 Jan 2020
21 CFR 117.35(b)(2)

Toxic Chemicals - identified, held, stored

Cited by Ashley Polizzotto, Peter M Trunk, Morgan J Matthews, Ashley Defilippis

2 Jan 2020
21 CFR 117.4

Training of employees and records

Cited by Ashley Polizzotto, Peter M Trunk, Morgan J Matthews, Ashley Defilippis

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 110.20(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.20(b)Cited across public-safe Form 483 observations1x
21 CFR 117.35(a)Cited across public-safe Form 483 observations1x
21 CFR 117.35(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 117.4Cited across public-safe Form 483 observations1x
21 CFR 117.80(c)Cited across public-safe Form 483 observations1x
21 CFR 123.12(a)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 observations

The full inspection record, as Atlas holds it, 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