Form 483

Gategourmet Inc., Unit #235 Form 483, 2017-04-26

FDA issued a Form 483 to Gategourmet Inc., Unit #235 on 2017-04-26 with 8 public-safe observations.

483· Form 483 issuedFoods & Cosmetics8 observations

Gategourmet Inc., Unit #235 · Sterling, United States · Issued April 26, 2017

Overview

  • 8 public-safe observations are available for this inspection.
  • 4 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.

26 Apr 2017
21 CFR 110.20(b)(5)

Safety lighting and glass

Cited by Austin B Appler, Kenya K Moon

26 Apr 2017
21 CFR 110.20(b)(5)

Safety lighting and glass

Cited by Austin B Appler, Kenya K Moon

26 Apr 2017
21 CFR 110.80(b)(3)

Holding foods - refrigerate/freeze/heat

Cited by Austin B Appler, Kenya K Moon

26 Apr 2017
21 CFR 110.80(b)(3)

Holding foods - refrigerate/freeze/heat

Cited by Austin B Appler, Kenya K Moon

26 Apr 2017
21 CFR 1250.30(a)

Clean and free from flies, rodents, and other vermin

Cited by Austin B Appler, Kenya K Moon

Inspected site

GIGategourmet Inc., Unit #235Sterling, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(b)(5)Cited across public-safe Form 483 observations2x
21 CFR 110.80(b)(3)Cited across public-safe Form 483 observations2x
21 CFR 1250.30(a)Cited across public-safe Form 483 observations2x
21 CFR 1250.32(b)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 8 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