Form 483

Gate Gourmet, Inc. Form 483, 2017-08-31

FDA issued a Form 483 to Gate Gourmet, Inc. on 2017-08-31 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Gate Gourmet, Inc. · Seattle, United States · Issued August 31, 2017

Overview

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

31 Aug 2017
21 CFR 117.35(b)(1)

Cleaning and sanitizing substances- safe and adequate

Cited by Julia E Chervoni

31 Aug 2017
21 CFR 117.35(b)(1)

Cleaning and sanitizing substances- safe and adequate

Cited by Julia E Chervoni

31 Aug 2017
21 CFR 117.20(b)

Plant Construction and Design

Cited by Julia E Chervoni

31 Aug 2017
21 CFR 117.20(b)

Plant Construction and Design

Cited by Julia E Chervoni

31 Aug 2017
21 CFR 117.80(c)

Manufacturing, Processing, Packing, Holding - Controls

Cited by Julia E Chervoni

Inspected site

GGGate Gourmet, Inc.Seattle, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.20(b)Cited across public-safe Form 483 observations2x
21 CFR 117.35(b)(1)Cited across public-safe Form 483 observations2x
21 CFR 117.80(c)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 6 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