Form 483

Gate Gourmet, Inc Form 483, 2012-02-06

FDA issued a Form 483 to Gate Gourmet, Inc on 2012-02-06 with 2 public-safe observations.

483· Form 483 issued2 observations

Gate Gourmet, Inc · San Antonio, United States · Issued February 6, 2012

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.

6 Feb 2012
21 CFR 110.80(b)(1)

Maintenance of equip., utensils, and finished food packaging

Cited by Martha S Baldwin

6 Feb 2012
21 CFR 110.80(b)(8)

Metal / extraneous materials

Cited by Martha S Baldwin

Inspected site

GGGate Gourmet, IncSan Antonio, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.80(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(8)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