Atlas

Form 483

Calbee North America, LLC Form 483, 2017-09-01

FDA issued a Form 483 to Calbee North America, LLC on 2017-09-01 with 1 public-safe observation.

483· Form 483 issuedFoods & Cosmetics1 observation

Calbee North America, LLC · Boardman, United States · Issued September 1, 2017

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

1 Sep 2017
21 CFR 110.93

Storage/transportation of finished goods (deterioration)

Cited by Amy R Glynn

Inspected site

CNCalbee North America, LLCBoardman, United States

Inspection team

ARAmy R Glynn

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.93Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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