Form 483

5000 Years Foods, Inc. Form 483, 2016-11-08

FDA issued a Form 483 to 5000 Years Foods, Inc. on 2016-11-08 with 7 public-safe observations.

483· Form 483 issuedFoods & Cosmetics7 observations

5000 Years Foods, Inc. · Des Plaines, United States · Issued November 8, 2016

Overview

  • 7 public-safe observations are available for this inspection.
  • 7 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

8 Nov 2016
21 CFR 110.20(b)(4)

Floors, walls and ceilings

Cited by Pablo Alcantara

8 Nov 2016
21 CFR 110.35(a)

Buildings/sanitary

Cited by Pablo Alcantara

8 Nov 2016
21 CFR 110.40(a)

Installation and maintenance of equipment (S)

Cited by Pablo Alcantara

8 Nov 2016
21 CFR 110.40(b)

Seams on food contact surfaces

Cited by Pablo Alcantara

8 Nov 2016
21 CFR 110.80(b)(1)

Teardown equipment/thorough cleaning

Cited by Pablo Alcantara

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 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 110.40(b)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.93Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 7 observations

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