Atlas

Form 483

Gate Gourmet, Inc. Form 483, 2010-11-23

FDA issued a Form 483 to Gate Gourmet, Inc. on 2010-11-23 with 2 public-safe observations.

483· Form 483 issued2 observations

Gate Gourmet, Inc. · Dallas, United States · Issued November 23, 2010

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

23 Nov 2010
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Martha S Baldwin

23 Nov 2010
21 CFR 110.80(b)(7)

Equipment, containers, utensils

Cited by Martha S Baldwin

Inspected site

GGGate Gourmet, Inc.Dallas, United States

Inspection team

MSMartha S Baldwin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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