Form 483

Northern Tier Bakery LLC Form 483, 2009-04-10

FDA issued a Form 483 to Northern Tier Bakery LLC on 2009-04-10 with 5 public-safe observations.

483· Form 483 issued5 observations

Northern Tier Bakery LLC · Saint Paul Park, United States · Issued April 10, 2009

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.

10 Apr 2009
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Paola E Lathrop, Heather A Kleimola Hulbert, Frank S Sedzielarz

10 Apr 2009
21 CFR 123.6(b)

HACCP plan implementation

Cited by Paola E Lathrop, Heather A Kleimola Hulbert, Frank S Sedzielarz

10 Apr 2009
21 CFR 123.6(c)(5)

Corrective action plan

Cited by Paola E Lathrop, Heather A Kleimola Hulbert, Frank S Sedzielarz

10 Apr 2009
21 CFR 123.8(a)(1)

Reassessment of HACCP plan

Cited by Paola E Lathrop, Heather A Kleimola Hulbert, Frank S Sedzielarz

10 Apr 2009
21 CFR 123.11(b)

Sanitation monitoring

Cited by Paola E Lathrop, Heather A Kleimola Hulbert, Frank S Sedzielarz

Inspected site

NTNorthern Tier Bakery LLCSaint Paul Park, United States

Inspection team

HAHeather A Kleimola Hulbert

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)(1)Cited 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