Form 483

5000 Years Foods, Inc. Form 483, 2009-07-31

FDA issued a Form 483 to 5000 Years Foods, Inc. on 2009-07-31 with 5 public-safe observations.

483· Form 483 issued5 observations

5000 Years Foods, Inc. · Des Plaines, United States · Issued July 31, 2009

Overview

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

31 Jul 2009
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Rafael Padilla

31 Jul 2009
21 CFR 110.80

Reasonable precautions

Cited by Rafael Padilla

31 Jul 2009
21 CFR 110.80(b)(13)

Filling, assembling, packing controls

Cited by Rafael Padilla

31 Jul 2009
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Rafael Padilla

31 Jul 2009
21 CFR 123.8(a)(2)(ii)

Calibration - adequacy

Cited by Rafael Padilla

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 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(13)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(4)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(2)(ii)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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