Form 483

Maribel's Sweets, Inc. Form 483, 2022-06-30

FDA issued a Form 483 to Maribel's Sweets, Inc. on 2022-06-30 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Maribel's Sweets, Inc. · Brooklyn, United States · Issued June 30, 2022

Overview

  • 4 public-safe observations are available for this inspection.
  • 3 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.

30 Jun 2022
21 CFR 117.130(a)(1)

Hazard analysis - Identification of hazard

Cited by Tracy M Portelli, Paul M Gelfand

30 Jun 2022
21 CFR 117.135(a)(1)

Allergen preventive controls - Implement

Cited by Tracy M Portelli, Paul M Gelfand

30 Jun 2022
21 CFR 117.135(a)(1)

Process preventive controls - Implement

Cited by Tracy M Portelli, Paul M Gelfand

30 Jun 2022
21 CFR 117.135(c)(3)

Sanitation preventive controls - Appropriate (Adequate)

Cited by Tracy M Portelli, Paul M Gelfand

Inspected site

MSMaribel's Sweets, Inc.Brooklyn, United States

Inspection team

PMPaul M Gelfand

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