Form 483

Mars Wrigley Confectionery US, LLC Form 483, 2016-02-05

FDA issued a Form 483 to Mars Wrigley Confectionery US, LLC on 2016-02-05 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Mars Wrigley Confectionery US, LLC · Albany, United States · Issued February 5, 2016

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

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

5 Feb 2016
21 CFR 110.10(b)(9)

Precautions against contamination--micro, foreign substances

Cited by Anthony S Puckett, Janet B Gray, James Betz

5 Feb 2016
21 CFR 110.35(a)

Buildings/good repair

Cited by Anthony S Puckett, Janet B Gray, James Betz

5 Feb 2016
21 CFR 110.37(b)(3)

As source of contamination

Cited by Anthony S Puckett, Janet B Gray, James Betz

5 Feb 2016
21 CFR 110.80(b)(1)

Maintenance of equip., utensils, and finished food packaging

Cited by Anthony S Puckett, Janet B Gray, James Betz

5 Feb 2016
21 CFR 110.80(b)(7)

Equipment, containers, utensils

Cited by Anthony S Puckett, Janet B Gray, James Betz

Inspected site

MWMars Wrigley Confectionery US, LLCAlbany, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)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