Form 483

Gate Gourmet, Inc. Form 483, 2018-06-05

FDA issued a Form 483 to Gate Gourmet, Inc. on 2018-06-05 with 12 public-safe observations.

483· Form 483 issuedFoods & Cosmetics12 observations

Gate Gourmet, Inc. · Astoria, United States · Issued June 5, 2018

Overview

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

5 Jun 2018
21 CFR 110.80

Reasonable precautions

Cited by Sonia E Ortiz

5 Jun 2018
21 CFR 117.35(a)

Sanitary Operations - Plant Maintenance

Cited by Sonia E Ortiz

5 Jun 2018
21 CFR 117.37

Sanitary Facilities and Control

Cited by Sonia E Ortiz

5 Jun 2018
21 CFR 1250.33(a)

Maintained in good repair

Cited by Sonia E Ortiz

5 Jun 2018
21 CFR 110.80

Reasonable precautions

Cited by Sonia E Ortiz

Inspected site

GGGate Gourmet, Inc.Astoria, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.80Cited across public-safe Form 483 observations2x
21 CFR 117.35(a)Cited across public-safe Form 483 observations2x
21 CFR 117.37Cited across public-safe Form 483 observations2x
21 CFR 117.93Cited across public-safe Form 483 observations2x
21 CFR 1250.30(d)Cited across public-safe Form 483 observations2x
21 CFR 1250.33(a)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 12 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