Form 483

Wimberger's Old World Bakery, Inc. Form 483, 2012-07-27

FDA issued a Form 483 to Wimberger's Old World Bakery, Inc. on 2012-07-27 with 19 public-safe observations.

483· Form 483 issued19 observations

Wimberger's Old World Bakery, Inc. · Colorado Springs, United States · Issued July 27, 2012

Overview

  • 19 public-safe observations are available for this inspection.
  • 18 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 Jul 2012
21 CFR 110.10(b)(1)

Suitable outer garments

Cited by Brittany R Laymon, Lisa T Michel, Jennifer A Baker

27 Jul 2012
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Brittany R Laymon, Lisa T Michel, Jennifer A Baker

27 Jul 2012
21 CFR 110.10(b)(4)

Unsecured jewelry

Cited by Brittany R Laymon, Lisa T Michel, Jennifer A Baker

27 Jul 2012
21 CFR 110.10(b)(6)

Failure to wear

Cited by Brittany R Laymon, Lisa T Michel, Jennifer A Baker

27 Jul 2012
21 CFR 110.10(b)(8)

Personal food/drink/tobacco

Cited by Brittany R Laymon, Lisa T Michel, Jennifer A Baker

Inspected site

WOWimberger's Old World Bakery, Inc.Colorado Springs, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.40(a)Cited across public-safe Form 483 observations2x
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 110.10(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(8)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)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 110.35(d)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(8)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 19 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