Form 483

Ice Cream House LLC Form 483, 2023-09-26

FDA issued a Form 483 to Ice Cream House LLC on 2023-09-26 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Ice Cream House LLC · Brooklyn, United States · Issued September 26, 2023

Overview

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

Inspectional observations

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

26 Sep 2023
21 CFR 117.10

Personnel

Cited by Erica B Raphael, Melissa N Gregorio, Lirissia Mccoy, Erica B Brush

26 Sep 2023
21 CFR 117.130(a)(1)

Hazard analysis - Identification of hazard

Cited by Erica B Raphael, Melissa N Gregorio, Lirissia Mccoy, Erica B Brush

26 Sep 2023
21 CFR 117.135(c)(3)

Sanitation preventive controls - Appropriate (Adequate)

Cited by Erica B Raphael, Melissa N Gregorio, Lirissia Mccoy, Erica B Brush

26 Sep 2023
21 CFR 117.35(a)

Sanitary operations - Plant maintenance

Cited by Erica B Raphael, Melissa N Gregorio, Lirissia Mccoy, Erica B Brush

Inspected site

ICIce Cream House LLCBrooklyn, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.10Cited across public-safe Form 483 observations1x
21 CFR 117.130(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

Full 483 report

Get the verbatim text of all 4 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