Form 483

Saputo Dairy Foods USA, LLC Form 483, 2008-11-21

FDA issued a Form 483 to Saputo Dairy Foods USA, LLC on 2008-11-21 with 5 public-safe observations.

483· Form 483 issued5 observations

Saputo Dairy Foods USA, LLC · Frederick, United States · Issued November 21, 2008

Overview

  • 5 public-safe observations are available for this inspection.
  • 4 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.

21 Nov 2008
21 CFR 110.40(f)

Q.C. instrument accuracy, maintenance

Cited by Brian R Yaun

21 Nov 2008
21 CFR 113.40(g)(4)

Critical factors record - frequency

Cited by Brian R Yaun

21 Nov 2008
21 CFR 113.83

Critical factors not stated

Cited by Brian R Yaun

21 Nov 2008
21 CFR 113.89

Evaluation by process authority

Cited by Brian R Yaun

21 Nov 2008
21 CFR 113.89

Process deviation identification

Cited by Brian R Yaun

Inspected site

SDSaputo Dairy Foods USA, LLCFrederick, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 113.89Cited across public-safe Form 483 observations2x
21 CFR 110.40(f)Cited across public-safe Form 483 observations1x
21 CFR 113.40(g)(4)Cited across public-safe Form 483 observations1x
21 CFR 113.83Cited 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