Form 483

Gracie's Kitchens Inc. Form 483, 2024-05-08

FDA issued a Form 483 to Gracie's Kitchens Inc. on 2024-05-08 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

Gracie's Kitchens Inc. · New Haven, United States · Issued May 8, 2024

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

8 May 2024
21 CFR 117.130(a)(1)

Hazard analysis - Identification of hazard

Cited by Kimberly M White, Lirissia Mccoy, Isaac N Baah

8 May 2024
21 CFR 117.135(a)(1)

Sanitation preventive controls - Implement

Cited by Kimberly M White, Lirissia Mccoy, Isaac N Baah

8 May 2024
21 CFR 117.135(c)(3)

Sanitation preventive controls - Appropriate (Adequate)

Cited by Kimberly M White, Lirissia Mccoy, Isaac N Baah

8 May 2024
21 CFR 117.35(a)

Sanitary operations - Plant maintenance

Cited by Kimberly M White, Lirissia Mccoy, Isaac N Baah

8 May 2024
21 CFR 117.35(b)(1)

Cleaning and sanitizing substances - Safe and adequate

Cited by Kimberly M White, Lirissia Mccoy, Isaac N Baah

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 117.135(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.135(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 117.35(a)Cited across public-safe Form 483 observations1x
21 CFR 117.35(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.410(c)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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