Form 483

Gate Gourmet, Inc. Form 483, 2009-11-05

FDA issued a Form 483 to Gate Gourmet, Inc. on 2009-11-05 with 3 public-safe observations.

483· Form 483 issued3 observations

Gate Gourmet, Inc. · Dallas, United States · Issued November 5, 2009

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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 Nov 2009
21 CFR 110.10(b)(9)

Precautions against contamination--micro, foreign substances

Cited by Martha S Baldwin

5 Nov 2009
21 CFR 110.20(b)(7)

Screening

Cited by Martha S Baldwin

5 Nov 2009
21 CFR 1250.32(a)

Contamination

Cited by Martha S Baldwin

Inspected site

GGGate Gourmet, Inc.Dallas, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 1250.32(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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