Form 483

Gracie's Kitchens Inc. Form 483, 2015-08-04

FDA issued a Form 483 to Gracie's Kitchens Inc. on 2015-08-04 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Gracie's Kitchens Inc. · New Haven, United States · Issued August 4, 2015

Overview

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

4 Aug 2015
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Brenna L Macdowell, Rebecca B Welch

4 Aug 2015
21 CFR 123.6(b)

No HACCP plan

Cited by Brenna L Macdowell, Rebecca B Welch

4 Aug 2015
21 CFR 123.11(b)

Sanitation monitoring documentation

Cited by Brenna L Macdowell, Rebecca B Welch

4 Aug 2015
21 CFR 123.11(c)

Sanitation Records

Cited by Brenna L Macdowell, Rebecca B Welch

Inspected site

GKGracie's Kitchens Inc.New Haven, United States

Inspection team

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 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.11(c)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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