Form 483

Rise Baking Company, LLC Form 483, 2012-09-27

FDA issued a Form 483 to Rise Baking Company, LLC on 2012-09-27 with 6 public-safe observations.

483· Form 483 issued6 observations

Rise Baking Company, LLC · Eagan, United States · Issued September 27, 2012

Overview

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

27 Sep 2012
21 CFR 110.35(a)

Buildings/sanitary

Cited by Maria E Treadwell, Amy L Mcintyre, Karen M Labounty

27 Sep 2012
21 CFR 110.35(d)

Failure to clean - general

Cited by Maria E Treadwell, Amy L Mcintyre, Karen M Labounty

27 Sep 2012
21 CFR 110.37(e)

Running water at suitable temperature

Cited by Maria E Treadwell, Amy L Mcintyre, Karen M Labounty

27 Sep 2012
21 CFR 110.80

Reasonable precautions

Cited by Maria E Treadwell, Amy L Mcintyre, Karen M Labounty

27 Sep 2012
21 CFR 114.80(a)(1)

Scheduled process

Cited by Maria E Treadwell, Amy L Mcintyre, Karen M Labounty

Inspected site

RBRise Baking Company, LLCEagan, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 114.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 114.89Cited 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