Form 483

5000 Years Foods, Inc. Form 483, 2022-08-17

FDA issued a Form 483 to 5000 Years Foods, Inc. on 2022-08-17 with 24 public-safe observations.

483· Form 483 issuedFoods & Cosmetics24 observations

5000 Years Foods, Inc. · Des Plaines, United States · Issued August 17, 2022

Overview

  • 24 public-safe observations are available for this inspection.
  • 8 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.

17 Aug 2022
21 CFR 117.130(a)(1)

Hazard analysis - Identification of hazard

Cited by Pablo Alcantara, Chase S Baldwin, Jennifer A D'Angelo, Roshni J Patel

17 Aug 2022
21 CFR 117.130(a)(1)

Hazard analysis - Identification of hazard

Cited by Pablo Alcantara, Chase S Baldwin, Jennifer A D'Angelo, Roshni J Patel

17 Aug 2022
21 CFR 117.135(a)(1)

Sanitation preventive controls - Implement

Cited by Pablo Alcantara, Chase S Baldwin, Jennifer A D'Angelo, Roshni J Patel

17 Aug 2022
21 CFR 117.135(a)(1)

Sanitation preventive controls - Implement

Cited by Pablo Alcantara, Chase S Baldwin, Jennifer A D'Angelo, Roshni J Patel

17 Aug 2022
21 CFR 117.135(c)(2)

Allergen preventive controls - Appropriate (Adequate)

Cited by Pablo Alcantara, Chase S Baldwin, Jennifer A D'Angelo, Roshni J Patel

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 117.130(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 117.135(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 117.135(c)(2)Cited across public-safe Form 483 observations3x
21 CFR 117.135(c)(3)Cited across public-safe Form 483 observations3x
21 CFR 117.139(b)Cited across public-safe Form 483 observations3x
21 CFR 117.35(c)Cited across public-safe Form 483 observations3x
21 CFR 117.405(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 117.80(c)Cited across public-safe Form 483 observations3x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 24 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