Form 483

Gourmet Cuisine, Inc. Form 483, 2010-05-06

FDA issued a Form 483 to Gourmet Cuisine, Inc. on 2010-05-06 with 13 public-safe observations.

483· Form 483 issued13 observations

Gourmet Cuisine, Inc. · Mesquite, United States · Issued May 6, 2010

Overview

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

Inspectional observations

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

6 May 2010
21 CFR 110.10(a)

Employees with illness, lesions, contamination source

Cited by Ashley N Williams, Tamera H Hunt

6 May 2010
21 CFR 110.10(b)(6)

Effective use of hair restraint

Cited by Ashley N Williams, Tamera H Hunt

6 May 2010
21 CFR 110.35(d)(5)

Safe and adequate for use

Cited by Ashley N Williams, Tamera H Hunt

6 May 2010
21 CFR 110.37(e)

Running water at suitable temperature

Cited by Ashley N Williams, Tamera H Hunt

6 May 2010
21 CFR 110.80(b)(7)

Equipment, containers, utensils

Cited by Ashley N Williams, Tamera H Hunt

Inspected site

GCGourmet Cuisine, Inc.Mesquite, United States

Inspection team

THTamera H Hunt

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(b)Cited across public-safe Form 483 observations2x
21 CFR 110.10(a)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 114.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 114.89Cited across public-safe Form 483 observations1x
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(1)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(6)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 13 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