Form 483

Gate Gourmet, Inc. Form 483, 2025-02-04

FDA issued a Form 483 to Gate Gourmet, Inc. on 2025-02-04 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Gate Gourmet, Inc. · Dallas, United States · Issued February 4, 2025

Overview

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

Inspectional observations

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

4 Feb 2025
21 CFR 117.135(c)(1)

Process preventive controls - Appropriate (Adequate)

Cited by Ninfa N Innocent, Kayla R Deatherage, Naasra Akram

4 Feb 2025
21 CFR 117.35(a)

Sanitary operations - Plant maintenance

Cited by Ninfa N Innocent, Kayla R Deatherage, Naasra Akram

4 Feb 2025
21 CFR 117.37

Sanitary facilities and controls

Cited by Ninfa N Innocent, Kayla R Deatherage, Naasra Akram

Inspected site

GGGate Gourmet, Inc.Dallas, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.135(c)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.35(a)Cited across public-safe Form 483 observations1x
21 CFR 117.37Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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