Form 483

Fresh Express Incorporated Form 483, 2017-12-20

FDA issued a Form 483 to Fresh Express Incorporated on 2017-12-20 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Fresh Express Incorporated · Streamwood, United States · Issued December 20, 2017

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

20 Dec 2017
21 CFR 117.40

Equipment and Utensils - Design and Maintenance

Cited by Daniel B Arrecis, Pablo Alcantara

20 Dec 2017
21 CFR 117.40

Equipment and Utensils - Design and Maintenance

Cited by Daniel B Arrecis, Pablo Alcantara

Inspected site

FEFresh Express IncorporatedStreamwood, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.40Cited across public-safe Form 483 observations2x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 2 observations

The source PDF and 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