Atlas

Form 483

Garden-Fresh Foods, Inc. Form 483, 2022-03-07

FDA issued a Form 483 to Garden-Fresh Foods, Inc. on 2022-03-07 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Garden-Fresh Foods, Inc. · Milwaukee, United States · Issued March 7, 2022

Overview

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

Inspectional observations

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

7 Mar 2022
21 CFR 117.135(a)(1)

Preventive Controls - Identify

Cited by Jamie R Thompson, Karen M Gasperic

7 Mar 2022
21 CFR 117.145(a)

Allergen Controls Monitoring Proced: Establish Implement

Cited by Jamie R Thompson, Karen M Gasperic

7 Mar 2022
21 CFR 117.145(a)

Process Controls Monitoring Procedures: Establish Implement

Cited by Jamie R Thompson, Karen M Gasperic

Inspected site

GFGarden-Fresh Foods, Inc.Milwaukee, United States

Inspection team

JRJamie R Thompson
KMKaren M Gasperic

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.145(a)Cited across public-safe Form 483 observations2x
21 CFR 117.135(a)(1)Cited 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