Form 483

La Sonorense, Inc. Form 483, 2025-01-17

FDA issued a Form 483 to La Sonorense, Inc. on 2025-01-17 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

La Sonorense, Inc. · Phoenix, United States · Issued January 17, 2025

Overview

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

17 Jan 2025
21 CFR 117.135(a)(1)

Allergen preventive controls - Implement

Cited by Patricia P Wrona, Matthew R Miranda, Megan K Rand

17 Jan 2025
21 CFR 117.135(a)(1)

Sanitation preventive controls - Implement

Cited by Patricia P Wrona, Matthew R Miranda, Megan K Rand

17 Jan 2025
21 CFR 117.80(c)

Manufacturing, processing, packing, holding - Controls

Cited by Patricia P Wrona, Matthew R Miranda, Megan K Rand

17 Jan 2025
21 CFR 117.95(a)

Human food by-products

Cited by Patricia P Wrona, Matthew R Miranda, Megan K Rand

Inspected site

LSLa Sonorense, Inc.Phoenix, 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 117.80(c)Cited across public-safe Form 483 observations1x
21 CFR 117.95(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