Form 483

La Sonorense, Inc. Form 483, 2023-05-26

FDA issued a Form 483 to La Sonorense, Inc. on 2023-05-26 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

La Sonorense, Inc. · Phoenix, United States · Issued May 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 May 2023
21 CFR 117.130(a)(1)

Hazard analysis - Identification of hazard

Cited by James P Stallings, Erica R Woody, Patricia P Wrona, Erica R Havely

26 May 2023
21 CFR 117.135(c)(2)

Allergen preventive controls - Appropriate (Adequate)

Cited by James P Stallings, Erica R Woody, Patricia P Wrona, Erica R Havely

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

Sanitation preventive controls - Appropriate (Adequate)

Cited by James P Stallings, Erica R Woody, Patricia P Wrona, Erica R Havely

26 May 2023
21 CFR 117.35(a)

Sanitary operations - Plant sanitation

Cited by James P Stallings, Erica R Woody, Patricia P Wrona, Erica R Havely

Inspected site

LSLa Sonorense, Inc.Phoenix, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.130(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.135(c)(2)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