Form 483

Maribel's Sweets, Inc. Form 483, 2024-11-04

FDA issued a Form 483 to Maribel's Sweets, Inc. on 2024-11-04 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Maribel's Sweets, Inc. · Brooklyn, United States · Issued November 4, 2024

Overview

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

Inspectional observations

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

4 Nov 2024
21 CFR 117.135(a)(1)

Allergen preventive controls - Implement

Cited by Melissa N Gregorio

4 Nov 2024
21 CFR 117.135(a)(1)

Sanitation preventive controls - Implement

Cited by Melissa N Gregorio

4 Nov 2024
21 CFR 117.405(a)(1)

Supply-chain program - Implement

Cited by Melissa N Gregorio

Inspected site

MSMaribel's Sweets, Inc.Brooklyn, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.135(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 117.405(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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