Form 483

Gate Gourmet, Inc. Form 483, 2017-10-06

FDA issued a Form 483 to Gate Gourmet, Inc. on 2017-10-06 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Gate Gourmet, Inc. · Los Angeles, United States · Issued October 6, 2017

Overview

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

6 Oct 2017
21 CFR 117.10

Personnel

Cited by Nianna C Burns

6 Oct 2017
21 CFR 117.206(a)

Modified Requirement Temp Control - Monitor, Corrective Acti

Cited by Nianna C Burns

6 Oct 2017
21 CFR 117.35(a)

Sanitary Operations - Plant Maintenance

Cited by Nianna C Burns

6 Oct 2017
21 CFR 117.35(a)

Sanitary Operations - Plant Sanitation

Cited by Nianna C Burns

6 Oct 2017
21 CFR 117.37

Sanitary Facilities and Control

Cited by Nianna C Burns

Inspected site

GGGate Gourmet, Inc.Los Angeles, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.35(a)Cited across public-safe Form 483 observations2x
21 CFR 117.10Cited across public-safe Form 483 observations1x
21 CFR 117.206(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 5 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