Form 483

La Sonorense, Inc. Form 483, 2019-01-11

FDA issued a Form 483 to La Sonorense, Inc. on 2019-01-11 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

La Sonorense, Inc. · Phoenix, United States · Issued January 11, 2019

Overview

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

11 Jan 2019
21 CFR 117.10

Personnel

Cited by James P Stallings

11 Jan 2019
21 CFR 117.35(a)

Sanitary Operations - Plant Maintenance

Cited by James P Stallings

11 Jan 2019
21 CFR 117.35(a)

Sanitary Operations - Plant Sanitation

Cited by James P Stallings

11 Jan 2019
21 CFR 117.35(b)(2)

Toxic Chemicals - identified, held, stored

Cited by James P Stallings

Inspected site

LSLa Sonorense, Inc.Phoenix, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.35(a)Cited across public-safe Form 483 observations2x
21 CFR 117.10Cited across public-safe Form 483 observations1x
21 CFR 117.35(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 observations

Every observation in full, 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