Form 483

La Milagrosa 1 LLC Form 483, 2024-10-23

FDA issued a Form 483 to La Milagrosa 1 LLC on 2024-10-23 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

La Milagrosa 1 LLC · Passaic, United States · Issued October 23, 2024

Overview

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

23 Oct 2024
21 CFR 117.126(a)(1)

Food safety plan

Cited by Jessica M Monteiro, Rodrigo Vilchez, Gillian B Nardelli, Dena M Elimam

23 Oct 2024
21 CFR 117.37

Sanitary facilities and controls

Cited by Jessica M Monteiro, Rodrigo Vilchez, Gillian B Nardelli, Dena M Elimam

23 Oct 2024
21 CFR 117.40

Equipment and utensils - Design and maintenance

Cited by Jessica M Monteiro, Rodrigo Vilchez, Gillian B Nardelli, Dena M Elimam

Inspected site

LMLa Milagrosa 1 LLCPassaic, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.126(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.37Cited across public-safe Form 483 observations1x
21 CFR 117.40Cited 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