Form 483

Gracie's Kitchens Inc. Form 483, 2023-03-22

FDA issued a Form 483 to Gracie's Kitchens Inc. on 2023-03-22 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Gracie's Kitchens Inc. · New Haven, United States · Issued March 22, 2023

Overview

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

Inspectional observations

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

22 Mar 2023
21 CFR 117.130(a)(1)

Hazard analysis - Identification of hazard

Cited by Lirissia Mccoy, Isaac N Baah, Brenna L MacDowell

22 Mar 2023
21 CFR 117.4

Qualifications of individuals

Cited by Lirissia Mccoy, Isaac N Baah, Brenna L MacDowell

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 117.130(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.4Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 observations

The full inspection record, as Atlas holds it, 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