Form 483

Northern Tier Bakery LLC Form 483, 2010-03-26

FDA issued a Form 483 to Northern Tier Bakery LLC on 2010-03-26 with 10 public-safe observations.

483· Form 483 issued10 observations

Northern Tier Bakery LLC · Saint Paul Park, United States · Issued March 26, 2010

Overview

  • 10 public-safe observations are available for this inspection.
  • 10 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.

26 Mar 2010
21 CFR 110.10(b)(1)

Suitable outer garments

Cited by Elizabeth P Mayer, Amy L Mcintyre

26 Mar 2010
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Elizabeth P Mayer, Amy L Mcintyre

26 Mar 2010
21 CFR 110.80(b)(2)

Manufacturing conditions

Cited by Elizabeth P Mayer, Amy L Mcintyre

26 Mar 2010
21 CFR 110.80(b)(7)

Equipment, containers, utensils

Cited by Elizabeth P Mayer, Amy L Mcintyre

26 Mar 2010
21 CFR 110.80(b)(13)

Filling, assembling, packing controls

Cited by Elizabeth P Mayer, Amy L Mcintyre

Inspected site

NTNorthern Tier Bakery LLCSaint Paul Park, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(13)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 123.11(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(5)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(6)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(7)Cited across public-safe Form 483 observations1x
21 CFR 123.8(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 10 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