Atlas

Form 483

Saputo Dairy Foods USA, LLC Form 483, 2011-08-22

FDA issued a Form 483 to Saputo Dairy Foods USA, LLC on 2011-08-22 with 2 public-safe observations.

483· Form 483 issued2 observations

Saputo Dairy Foods USA, LLC · White Bear Lake, United States · Issued August 22, 2011

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

22 Aug 2011
21 CFR 113.89

Methods of process deviation evaluation

Cited by Elizabeth P Mayer, Karen M Labounty

22 Aug 2011
21 CFR 113.100(a)

Critical factors - no record

Cited by Elizabeth P Mayer, Karen M Labounty

Inspected site

SDSaputo Dairy Foods USA, LLCWhite Bear Lake, United States

Inspection team

EPElizabeth P Mayer
KMKaren M Labounty

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 113.100(a)Cited across public-safe Form 483 observations1x
21 CFR 113.89Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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