Form 483

Rise Baking Company, LLC Form 483, 2009-12-17

FDA issued a Form 483 to Rise Baking Company, LLC on 2009-12-17 with 12 public-safe observations.

483· Form 483 issued12 observations

Rise Baking Company, LLC · Eagan, United States · Issued December 17, 2009

Overview

  • 12 public-safe observations are available for this inspection.
  • 11 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.

17 Dec 2009
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Grant M Ruis, Karen M Labounty, Mada A Tautges

17 Dec 2009
21 CFR 110.10(b)(6)

Effective use of hair restraint

Cited by Grant M Ruis, Karen M Labounty, Mada A Tautges

17 Dec 2009
21 CFR 110.10(b)(6)

Failure to wear

Cited by Grant M Ruis, Karen M Labounty, Mada A Tautges

17 Dec 2009
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Grant M Ruis, Karen M Labounty, Mada A Tautges

17 Dec 2009
21 CFR 110.35(c)

Lack of effective pest exclusion

Cited by Grant M Ruis, Karen M Labounty, Mada A Tautges

Inspected site

RBRise Baking Company, LLCEagan, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations2x
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 114.100(c)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 12 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