Atlas

Form 483

5000 Years Foods, Inc. Form 483, 2025-08-26

FDA issued a Form 483 to 5000 Years Foods, Inc. on 2025-08-26 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

5000 Years Foods, Inc. · Des Plaines, United States · Issued August 26, 2025

Overview

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

26 Aug 2025
21 CFR 117.130(a)(1)

Hazard analysis - Conducted

Cited by Matthew R Buenconsejo, Roshni J Patel

26 Aug 2025
21 CFR 117.135(c)(1)

Process preventive controls - Appropriate (Adequate)

Cited by Matthew R Buenconsejo, Roshni J Patel

26 Aug 2025
21 CFR 117.135(c)(2)

Allergen preventive controls - Appropriate (Adequate)

Cited by Matthew R Buenconsejo, Roshni J Patel

26 Aug 2025
21 CFR 117.40

Equipment and utensils - Design and maintenance

Cited by Matthew R Buenconsejo, Roshni J Patel

26 Aug 2025
21 CFR 117.405(a)(1)

Supply-chain program - Implement

Cited by Matthew R Buenconsejo, Roshni J Patel

Inspected site

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

Inspection team

MRMatthew R Buenconsejo
RJRoshni J Patel

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.130(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.135(c)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.135(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 117.40Cited across public-safe Form 483 observations1x
21 CFR 117.405(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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