Form 483

5000 Years Foods, Inc. Form 483, 2021-08-03

FDA issued a Form 483 to 5000 Years Foods, Inc. on 2021-08-03 with 10 public-safe observations.

483· Form 483 issuedFoods & Cosmetics10 observations

5000 Years Foods, Inc. · Des Plaines, United States · Issued August 3, 2021

Overview

  • 10 public-safe observations are available for this inspection.
  • 5 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.

3 Aug 2021
21 CFR 117.126(a)(1)

Food safety plan

Cited by Pablo Alcantara, Chase S Baldwin, Matthew R Buenconsejo, Logan M Ebeling

3 Aug 2021
21 CFR 117.126(a)(1)

Food safety plan

Cited by Pablo Alcantara, Chase S Baldwin, Matthew R Buenconsejo, Logan M Ebeling

3 Aug 2021
21 CFR 117.35(a)

Sanitary operations - Plant maintenance

Cited by Pablo Alcantara, Chase S Baldwin, Matthew R Buenconsejo, Logan M Ebeling

3 Aug 2021
21 CFR 117.35(a)

Sanitary operations - Plant maintenance

Cited by Pablo Alcantara, Chase S Baldwin, Matthew R Buenconsejo, Logan M Ebeling

3 Aug 2021
21 CFR 117.35(c)

Pest control

Cited by Pablo Alcantara, Chase S Baldwin, Matthew R Buenconsejo, Logan M Ebeling

Inspected site

5Y5000 Years Foods, Inc.Des Plaines, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.126(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 117.35(a)Cited across public-safe Form 483 observations2x
21 CFR 117.35(c)Cited across public-safe Form 483 observations2x
21 CFR 117.40Cited across public-safe Form 483 observations2x
21 CFR 117.80(c)Cited across public-safe Form 483 observations2x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 10 observations

The source PDF, 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