Form 483

Saputo Dairy Foods USA, LLC Form 483, 2011-02-18

FDA issued a Form 483 to Saputo Dairy Foods USA, LLC on 2011-02-18 with 6 public-safe observations.

483· Form 483 issued6 observations

Saputo Dairy Foods USA, LLC · Plant City, United States · Issued February 18, 2011

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

18 Feb 2011
21 CFR 120.6(b)

Sanitation monitoring

Cited by Howard A Webley

18 Feb 2011
21 CFR 120.8(a)

HACCP plan not implemented

Cited by Howard A Webley

18 Feb 2011
21 CFR 120.8(b)(4)

HACCP plan - monitoring procedures not adequate

Cited by Howard A Webley

18 Feb 2011
21 CFR 120.10(c)

Corrective action documentation

Cited by Howard A Webley

18 Feb 2011
21 CFR 120.11(a)(1)

Verification activities - minimum

Cited by Howard A Webley

Inspected site

SDSaputo Dairy Foods USA, LLCPlant City, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 120.10(c)Cited across public-safe Form 483 observations1x
21 CFR 120.11(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 120.11(a)(1)(iv)Cited across public-safe Form 483 observations1x
21 CFR 120.6(b)Cited across public-safe Form 483 observations1x
21 CFR 120.8(a)Cited across public-safe Form 483 observations1x
21 CFR 120.8(b)(4)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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